Breast CancerPREACTNCT07467824
Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer
A study testing Prehabilitation: Exercise and nutrition in people with Breast Cancer and Breast Neoplasms, run by European University Miguel de Cervantes at 2 sites in Spain.
Trial summary
Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Prehabilitation: Exercise and nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Apr 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who have a newly confirmed diagnosis of stage 0-III breast cancer.
- Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-².
- Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy.
- Be able to perform supervised physical exercise, as determined by prior medical assessment.
- Understand and voluntarily sign the written informed consent before the start of the study.
Who cannot join
- Women with a diagnosis of metastatic breast cancer.
- Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure.
- Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others.
- Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise).
- Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Recoletas Campo Grande
Valladolid, Valladolid, 47007
Zandra Soto Pino, PhD, 0034983309472, zandramileny.soto@gruporecoletas.com
Julio Flores Rodríguez, MD, 0034983309472, julio.floresro.hcg@gruporecoletas.com
- Recruiting
Miguel de Cervantes European University
Valladolid, Valladolid, 47012
Francisco Javier Gutiérrez Pecharromán, +34 983001000 ext. 22293, fjgutierrez@uemc.es
Alejandro Santos-Lozano, PhD, +34 983001000 ext. 22292, asantos@uemc.es
About this study
Official title: Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial
Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as "the process in the cancer continuum that occurs between diagnosis and the start of treatment," remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.
Read the detailed description
The administration of breast cancer (BC) treatments is associated with various adverse events and acute toxicities that negatively affect molecular, functional, and clinical outcomes in patients with BC. Additionally, these adverse events may reduce treatment tolerance [e.g., relative dose intensity (RDI)], which has been shown to be associated with a worse prognosis in this population. Implementing a high-intensity concurrent training program and specific nutritional guidelines during this phase could reduce adverse treatment events and improve recovery. Likewise, including an unsupervised exercise program and nutritional guidelines during the rest of the cancer treatment may enhance the benefits obtained and improve different outcomes related to the patients' functionality, clinical status, quality of life, and treatment tolerance. Therefore, the aim of this study is to determine the effects of a prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on different outcomes in newly diagnosed women with BC.
This prospective, two-arm parallel randomized controlled trial will be conducted in Valladolid (Castilla y León, Spain). A total of 66 newly diagnosed women with BC will be recruited through medical and diagnostic appointments. Women will be recruited immediately after diagnosis and must be scheduled to receive neoadjuvant chemotherapy or hormone therapy, surgery, or radiation therapy. After completion of baseline study assessments, participants will be randomized to an experimental group or a control group. Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program during the medical treatment period. Participants in the control group will be asked to continue their usual care and will receive general recommendations for physical exercise and nutrition. Molecular (inflammation-related proteins, epinephrine and norepinephrine), functional (cardiorespiratory fitness, 30-Second Sit-to-Stand Test, Six-Minute Walk Test, handgrip strength and maximal voluntary isometric contraction), clinical (body composition, muscle thickness, and arm volume), and patient-reported (quality of life, upper-limb disability, fatigue, 24-hour nutritional record and food frequency questionnaire) outcomes will be assessed at baseline (week 0) and at various points during the scheduled cancer-associated treatments. Treatment tolerance (relative dose intensity, dose reduction, dose delay, early discontinuation of treatment, and number of patients completing the planned total dose) and treatment-related complications (seroma, infection; hematoma, wound dehiscence, persistent post-surgical pain, lymphedema, neuropathy, and thromboembolism) will be recorded throughout the continuum of treatments.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Prehabilitation: Exercise and nutrition
- Keywords
- prehabilitation, exercise, nutrition, training
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation: Exercise and nutritionOther
Prehabilitation phase:
- Exercise training: During a 2-4-week prehabilitation phase, participants will perform supervised concurrent training sessions, including a high-intensity circuit of multi-joint resistance exercises and a high-intensity interval training.
- Nutrition: A dietitian will implement a 2-4-week structured plan providing 25-30 kcal/kg/day, 1.2-1.5 g protein/kg/day, at least 150 g carbohydrates/day, and ≥5 meals/day. The plan will also ensure adequate vitamins and antioxidants and include guidance on portion distribution to meet recommended intake of all food groups.
Neoadjuvant or adjuvant treatment phase:
- Exercise training: After treatment begins, participants will follow a home-based training plan during treatment: 3 weekly elastic-band resistance sessions + ≥150 min/week aerobic exercise. First week supervised; then remote follow-up.
- Nutrition: The participants will continue the guidelines provided during the prehabilitation phase.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and nutrition group | Experimental | Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program (exercise and nutrition) during the treatment period. Receives: Other: Prehabilitation: Exercise and nutrition |
| Control group | No intervention | Participants assigned to this group will be asked to continue their usual care and will receive general recommendations for physical activity and nutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (peak oxygen consumption): Direct method
The change in peak oxygen consumption (ml·kg-¹·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Measured: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Cardiorespiratory fitness: Indirect method (30-Second Sit-to-Stand Test)
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Cardiorespiratory fitness: Indirect method (Six-Minute Walk Test)
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Secondary outcomes (30)
Handgrip strength
The change in handgrip strength (in kilograms) will be assessed. The Jamar® Smart hand dynamometer (Patterson Medical Ltd., Sammons Preston, Nottinghamshire, UK) will be used to assess handgrip strength.
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery, up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)
Upper-body maximal voluntary isometric contraction: Chest press
The change in the chest press maximal voluntary isometric contraction (MVIC) (in Newton) will be assessed. MVIC will be evaluated with the Chronojump Force Sensor Kit (Chronojump Boscosystems®, Barcelona, Spain) and the open-source Chronojump software 2.30.0 for Windows. Upper-body MVIC will be assessed using the unilateral chest press exercise.
Measured: Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)
Lower-body maximal voluntary isometric contraction: Squat
The change in the squat maximal voluntary isometric contraction (MVIC) (in Newton) will be assessed. MVIC will be evaluated with the Chronojump Force Sensor Kit (Chronojump Boscosystems®, Barcelona, Spain) and the open-source Chronojump software 2.30.0 for Windows. Lower-body MVIC will be assessed during the 90º knee-flexion squat test.
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Inflammation-related proteins
The change in the levels of inflammation-related proteins (in Normalized Protein eXpression levels, an arbitrary unit on a log2 scale) in plasma will be assessed. Venous samples will be collected. Plasma samples will be sent with dry ice to the Cobiomic laboratory of Olink ® Proteomics, Córdoba, Spain, which will analyze 1 μL of each sample using the Olink ® Target 96 Inflammation panel (Cobiomic Bioscience, S.L; https://olink.com/products/olink-target-96).
Measured: Baseline; up to 1 week after prehabilitation; 1 week after surgery or immediately after completion of the first treatment.
Epinephrine and norepinephrine
The change in the plasma concentration of epinephrine and norepinephrine (mg/l and ng/ml) will be assessed. Venous blood samples will be collected before the cardiopulmonary exercise testing and immediately afterwards. The plasma concentrations of epinephrine and norepinephrine will be analyzed using an enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline; 1 week before initiation of the first treatment (radiotherapy, chemotherapy or hormone therapy).
Weight
The change in the weight will be assessed by kilograms (kg).
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Height
The change in the height will be assessed by centimeters (cm).
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Body composition (Bioimpedance)
The change in body composition (%) will be assessed using the NUTRILAB bioimpedance device (AKERN Srl, Florence, Italy). This non-invasive method measures the body's resistance and reactance of the body to the passage of a low-intensity electric current and enables the determination of various body parameters. Bioimpedance provides accurate data on body composition. Users will be instructed to remove all metal-containing objects and remain in a supine position on a couch during the measurements, with the legs in 45° abduction, the shoulders in 30° abduction relative to the center of the body and the hands in pronation. After cleaning the skin with alcohol, two adhesive electrodes (Biatrodes Akern Srl, Florence, Italy) will be placed on the surface of the right hand and two on the right foot. The measurement results will be given in different unit measures depending on the specific variable assessed.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Muscle thickness: vastus lateralis
Muscle thickness (in centimeters) of the vastus lateralis will be measured using a real-time B-mode ultrasound device with a linear transducer. A water-soluble, hypoallergenic transmission gel will be applied to the probe, to serve as a conductive interface between the probe and the participant's skin. Sufficient gel will be used to prevent compression of the muscle by the probe.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Muscle thickness: rectus femoris
Muscle thickness (in centimeters) of the rectus femoris will be measured using a real-time B-mode ultrasound device with a linear transducer. A water-soluble, hypoallergenic transmission gel will be applied to the probe, to serve as a conductive interface between the probe and the participant's skin. Sufficient gel will be used to prevent compression of the muscle by the probe.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Arm volume
The change in total arm volume of both the affected and unaffected side (in mililiters) will be assessed using circumferential measurements taken on the affected and unaffected arms using a standard 1 cm tape measure (Orliman, Valencia, Spain) in direct contact with the skin and in the supine position with the shoulders abducted at 45° and the forearms supinated. Circumference measurements will start at the metacarpophalangeal joints and will be taken at 10 cm intervals (at 10, 20, 30, 40, and 50 cm) up the arm to the base of the axilla. Circumference measurements will be collected and converted into volume using the truncated cone (frustum) formula.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Health-related quality of life
The change in the score of quality of life will be assessed using The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This tool consists of 30 items, scored with a Likert scale, which are distributed in five functional subscales, three symptom subscales, six additional individual items, and a two-item global subscale.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Upper-limb disability
The change in the score of upper-limb functionality will be assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, consisting of 30 items and 2 optional modules aimed at evaluating this variable.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Self-reported pain
The change in the score of pain of the affected arm will be assessed through a Numeric Rating Scale (NRS), numbered from 0 "no pain at all" to 10 "worst pain imaginable".
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Fatigue
The change in the score of fatigue of the affected arm will be assessed through the Functional Assessment of Cancer Therapy Fatigue Scale (FACT-F) questionnaire, consisting of 40 items.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Fatigue
The change in the score of fatigue of the affected arm will be assessed through the Piper Fatigue Scale-Revised (S-PFS-R), which consists of 22, 11-point (0-10) numeric rating scales that assess fatigue by patient self-report.
Measured: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Dietary intake
The change in the dietary intake will be assessed with a Food Frequency Questionnaire (FFQ). This tool measures how often foods and food groups are consumed over a specific period, enabling the estimation of typical dietary patterns.
Measured: Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Treatment-related complications
The following oncologic treatments complications will be assessed for occurrence: Seroma, infection, hematoma, wound dehiscence, persistent postoperative pain, lymphoedema, neuropathy, and thromboembolism.
Measured: Through study completion, an average of 1 year.
Length of hospitalization
The total number of days of hospitalization will be recorded.
Measured: Through study completion, an average of 1 year.
Physical activity levels
The levels of physical activity will be recorded using the International Physical Activity Questionnaire - Long Form (score).
Measured: Baseline and up to 4 weeks.
Cardiorespiratory fitness (peak ventilation)
The change in peak ventilation (L·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Measured: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Cardiorespiratory fitness (mean and peak heart rate)
The change in mean and peak heart rate (beats·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Measured: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Cardiorespiratory fitness (peak respiratory quotient)
The change in peak respiratory quotient (unitless) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Measured: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Physical function (30-Second Sit-to-Stand Test)
The change in the number of repetitions will be assessed.
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Physical function (Six-Minute Walk Test)
The change in the number of meters walked will be assessed.
Measured: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Treatment tolerance (relative dose intensity)
The ratio of delivered to prescribed therapy dose will be recorded, and relative dose intensity (RDI) will be calculated as (delivered dose/standard dose) × 100.
Measured: Through study completion, an average of 1 year.
Treatment tolerance (dose reduction)
Dose reduction will be calculated as the percentage difference between the planned dose and the administered dose in subsequent cycles.
Measured: Through study completion, an average of 1 year.
Treatment tolerance (dose delay)
The number of patients experiencing at least one delay and the total number of delayed cycles will be recorded
Measured: Through study completion, an average of 1 year.
Treatment tolerance (early treatment discontinuation)
The proportion of patients who discontinue treatment prematurely will be recorded.
Measured: Through study completion, an average of 1 year.
Treatment tolerance (completion of planned total dose)
The number of patients who complete the full planned chemotherapy regimen without early treatment discontinuation will be recorded
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start14 Apr 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective single-center randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Santos Lozano, PhD, Principal investigator, Miguel de Cervantes European University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467824
- Sponsor's protocol ID
- PI-DOC011-PREACT
- Acronym
- PREACT
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foulkes SJ, Howden EJ, Haykowsky MJ, Antill Y, Salim A, Nightingale SS, Loi S, Claus P, Janssens K, Mitchell AM, Wright L, Costello BT, Lindqvist A, Burnham L, Wallace I, Daly RM, Fraser SF, La Gerche A. Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. Circulation. 2023 Feb 14;147(7):532-545. doi: 10.1161/CIRCULATIONAHA.122.062814. Epub 2022 Nov 7.
PubMed 36342348Forsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15.
PubMed 23242613Jiang M, Ma Y, Yun B, Wang Q, Huang C, Han L. Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. Int J Nurs Sci. 2020 Mar 10;7(2):248-254. doi: 10.1016/j.ijnss.2020.03.001. eCollection 2020 Apr 10.
PubMed 32685623Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350Torcasio R, Gallo Cantafio ME, Ikeda RK, Ganino L, Viglietto G, Amodio N. Lipid metabolic vulnerabilities of multiple myeloma. Clin Exp Med. 2023 Nov;23(7):3373-3390. doi: 10.1007/s10238-023-01174-2. Epub 2023 Aug 28.
PubMed 37639069Demark-Wahnefried W, Campbell KL, Hayes SC. Weight management and its role in breast cancer rehabilitation. Cancer. 2012 Apr 15;118(8 Suppl):2277-87. doi: 10.1002/cncr.27466.
PubMed 22488702Schmid D, Leitzmann MF. Cardiorespiratory fitness as predictor of cancer mortality: a systematic review and meta-analysis. Ann Oncol. 2015 Feb;26(2):272-8. doi: 10.1093/annonc/mdu250. Epub 2014 Jul 9.
PubMed 25009011Chen X, Shi X, Yu Z, Ma X. High-intensity interval training in breast cancer patients: A systematic review and meta-analysis. Cancer Med. 2023 Sep;12(17):17692-17705. doi: 10.1002/cam4.6387. Epub 2023 Aug 17.
PubMed 37587859Castro-Espin C, Cairat M, Navionis AS, Dahm CC, Antoniussen CS, Tjonneland A, Mellemkjaer L, Mancini FR, Hajji-Louati M, Severi G, Le Cornet C, Kaaks R, Schulze MB, Masala G, Agnoli C, Sacerdote C, Crous-Bou M, Sanchez MJ, Amiano P, Chirlaque MD, Guevara M, Smith-Byrne K, Heath AK, Christakoudi S, Gunter MJ, Rinaldi S, Agudo A, Dossus L. Prognostic role of pre-diagnostic circulating inflammatory biomarkers in breast cancer survival: evidence from the EPIC cohort study. Br J Cancer. 2024 Nov;131(9):1496-1505. doi: 10.1038/s41416-024-02858-6. Epub 2024 Sep 28.
PubMed 39342063Ligibel JA, Dillon D, Giobbie-Hurder A, McTiernan A, Frank E, Cornwell M, Pun M, Campbell N, Dowling RJO, Chang MC, Tolaney S, Chagpar AB, Yung RL, Freedman RA, Dominici LS, Golshan M, Rhei E, Taneja K, Huang Y, Brown M, Winer EP, Jeselsohn R, Irwin ML. Impact of a Pre-Operative Exercise Intervention on Breast Cancer Proliferation and Gene Expression: Results from the Pre-Operative Health and Body (PreHAB) Study. Clin Cancer Res. 2019 Sep 1;25(17):5398-5406. doi: 10.1158/1078-0432.CCR-18-3143. Epub 2019 Apr 24.
PubMed 31018921Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.
PubMed 33072603Del Bianco N, Borsati A, Toniolo L, Ciurnielli C, Belluomini L, Insolda J, Sposito M, Milella M, Schena F, Pilotto S, Avancini A. What is the role of physical exercise in the era of cancer prehabilitation? A systematic review. Crit Rev Oncol Hematol. 2024 Jun;198:104350. doi: 10.1016/j.critrevonc.2024.104350. Epub 2024 Apr 18.
PubMed 38642726
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial
- ClinicalTrials.gov ID
- NCT07467824
- Acronym / sponsor ID
- PREACT / PI-DOC011-PREACT
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- prehabilitation, exercise, nutrition, training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as "the process in the cancer continuum that occurs between diagnosis and the start of treatment," remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.
Detailed description
The administration of breast cancer (BC) treatments is associated with various adverse events and acute toxicities that negatively affect molecular, functional, and clinical outcomes in patients with BC. Additionally, these adverse events may reduce treatment tolerance [e.g., relative dose intensity (RDI)], which has been shown to be associated with a worse prognosis in this population. Implementing a high-intensity concurrent training program and specific nutritional guidelines during this phase could reduce adverse treatment events and improve recovery. Likewise, including an unsupervised exercise program and nutritional guidelines during the rest of the cancer treatment may enhance the benefits obtained and improve different outcomes related to the patients' functionality, clinical status, quality of life, and treatment tolerance. Therefore, the aim of this study is to determine the effects of a prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on different outcomes in newly diagnosed women with BC.
This prospective, two-arm parallel randomized controlled trial will be conducted in Valladolid (Castilla y León, Spain). A total of 66 newly diagnosed women with BC will be recruited through medical and diagnostic appointments. Women will be recruited immediately after diagnosis and must be scheduled to receive neoadjuvant chemotherapy or hormone therapy, surgery, or radiation therapy. After completion of baseline study assessments, participants will be randomized to an experimental group or a control group. Participants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program during the medical treatment period. Participants in the control group will be asked to continue their usual care and will receive general recommendations for physical exercise and nutrition. Molecular (inflammation-related proteins, epinephrine and norepinephrine), functional (cardiorespiratory fitness, 30-Second Sit-to-Stand Test, Six-Minute Walk Test, handgrip strength and maximal voluntary isometric contraction), clinical (body composition, muscle thickness, and arm volume), and patient-reported (quality of life, upper-limb disability, fatigue, 24-hour nutritional record and food frequency questionnaire) outcomes will be assessed at baseline (week 0) and at various points during the scheduled cancer-associated treatments. Treatment tolerance (relative dose intensity, dose reduction, dose delay, early discontinuation of treatment, and number of patients completing the planned total dose) and treatment-related complications (seroma, infection; hematoma, wound dehiscence, persistent post-surgical pain, lymphedema, neuropathy, and thromboembolism) will be recorded throughout the continuum of treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective single-center randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Exercise and nutrition group | Experimental | Other: Prehabilitation: Exercise and nutritionParticipants assigned to the experimental group will undergo a supervised prehabilitation program consisting of structured exercise training and personalized nutritional guidelines, followed by a home-based program (exercise and nutrition) during the treatment period. |
| Control group | No intervention | –Participants assigned to this group will be asked to continue their usual care and will receive general recommendations for physical activity and nutrition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women who have a newly confirmed diagnosis of stage 0-III breast cancer.
- Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-².
- Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy.
- Be able to perform supervised physical exercise, as determined by prior medical assessment.
- Understand and voluntarily sign the written informed consent before the start of the study.
Key exclusion criteria (5 listed)
- Women with a diagnosis of metastatic breast cancer.
- Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure.
- Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others.
- Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise).
- Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation: Exercise and nutritionPrehabilitation phase: * Exercise training: During a 2-4-week prehabilitation phase, participants will perform supervised concurrent training sessions, including a high-intensity circuit of multi-joint resistance exercises and a high-intensity interval training. * Nutrition: A dietitian will implement a 2-4-week structured plan providing 25-30 kcal/kg/day, 1.2-1.5 g protein/kg/day, at least 150 g carbohydrates/day, and ≥5 meals/day. The plan will also ensure adequate vitamins and antioxidants and include guidance on portion distribution to meet recommended intake of all food groups. Neoadjuvant or adjuvant treatment phase: * Exercise training: After treatment begins, participants will follow a home-based training plan during treatment: 3 weekly elastic-band resistance sessions + ≥150 min/week aerobic exercise. First week supervised; then remote follow-up. * Nutrition: The participants will continue the guidelines provided during the prehabilitation phase. | Other | Exercise and nutrition group |
Primary outcome
Cardiorespiratory fitness (peak oxygen consumption): Direct method
Time frame: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
The change in peak oxygen consumption (ml·kg-¹·min-¹) will be assessed. A Wattbike AtomX cycle ergometer (Wattbike, Nottingham, England) and a stationary gas analyzer (Cortex Metalyzer 3B, Leipzig, Germany) will be used in the study. A gradual incremental exercise protocol will be applied, starting at 50 watts with increments of 25 watts every two minutes, until voluntary exhaustion is reached or medical reasons are presented to end exercise.
Cardiorespiratory fitness: Indirect method (30-Second Sit-to-Stand Test)
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
Cardiorespiratory fitness: Indirect method (Six-Minute Walk Test)
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
The change in the estimated peak of oxygen consumption (ml·kg-¹·min-¹) will be assessed.
30 secondary outcomes
Handgrip strength
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery, up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)
Upper-body maximal voluntary isometric contraction: Chest press
Time frame: Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks)
Lower-body maximal voluntary isometric contraction: Squat
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Inflammation-related proteins
Time frame: Baseline; up to 1 week after prehabilitation; 1 week after surgery or immediately after completion of the first treatment.
Epinephrine and norepinephrine
Time frame: Baseline; 1 week before initiation of the first treatment (radiotherapy, chemotherapy or hormone therapy).
Weight
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Height
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Body composition (Bioimpedance)
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Muscle thickness: vastus lateralis
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Muscle thickness: rectus femoris
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Arm volume
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Health-related quality of life
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Upper-limb disability
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Self-reported pain
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Fatigue
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Fatigue
Time frame: Baseline; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Dietary intake
Time frame: Baseline; up to 1 week after prehabilitation; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Treatment-related complications
Time frame: Through study completion, an average of 1 year.
Length of hospitalization
Time frame: Through study completion, an average of 1 year.
Physical activity levels
Time frame: Baseline and up to 4 weeks.
Cardiorespiratory fitness (peak ventilation)
Time frame: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Cardiorespiratory fitness (mean and peak heart rate)
Time frame: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Cardiorespiratory fitness (peak respiratory quotient)
Time frame: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.
Physical function (30-Second Sit-to-Stand Test)
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Physical function (Six-Minute Walk Test)
Time frame: Baseline; up to 1 week after prehabilitation; 1 week post-surgery; up to 1 week before systemic therapy; up to 1 week after systemic therapy; up to 1 week before radiotherapy; up to 1 week after radiotherapy; mid-chemotherapy (an average of 6 weeks).
Treatment tolerance (relative dose intensity)
Time frame: Through study completion, an average of 1 year.
Treatment tolerance (dose reduction)
Time frame: Through study completion, an average of 1 year.
Treatment tolerance (dose delay)
Time frame: Through study completion, an average of 1 year.
Treatment tolerance (early treatment discontinuation)
Time frame: Through study completion, an average of 1 year.
Treatment tolerance (completion of planned total dose)
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 36342348Foulkes SJ, Howden EJ, Haykowsky MJ, Antill Y, Salim A, Nightingale SS, Loi S, Claus P, Janssens K, Mitchell AM, Wright L, Costello BT, Lindqvist A, Burnham L, Wallace I, Daly RM, Fraser SF, La Gerche A. Exercise for the Prevention of Anthracycline-Induced Functional Disability and Cardiac Dysfunction: The BREXIT Study. Circulation. 2023 Feb 14;147(7):532-545. doi: 10.1161/CIRCULATIONAHA.122.062814. Epub 2022 Nov 7.
- Background: PubMed 23242613Forsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15.
- Background: PubMed 32685623Jiang M, Ma Y, Yun B, Wang Q, Huang C, Han L. Exercise for fatigue in breast cancer patients: An umbrella review of systematic reviews. Int J Nurs Sci. 2020 Mar 10;7(2):248-254. doi: 10.1016/j.ijnss.2020.03.001. eCollection 2020 Apr 10.
- Background: PubMed 33239350Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
- Background: PubMed 37639069Torcasio R, Gallo Cantafio ME, Ikeda RK, Ganino L, Viglietto G, Amodio N. Lipid metabolic vulnerabilities of multiple myeloma. Clin Exp Med. 2023 Nov;23(7):3373-3390. doi: 10.1007/s10238-023-01174-2. Epub 2023 Aug 28.
- Background: PubMed 22488702Demark-Wahnefried W, Campbell KL, Hayes SC. Weight management and its role in breast cancer rehabilitation. Cancer. 2012 Apr 15;118(8 Suppl):2277-87. doi: 10.1002/cncr.27466.
- Background: PubMed 25009011Schmid D, Leitzmann MF. Cardiorespiratory fitness as predictor of cancer mortality: a systematic review and meta-analysis. Ann Oncol. 2015 Feb;26(2):272-8. doi: 10.1093/annonc/mdu250. Epub 2014 Jul 9.
- Background: PubMed 37587859Chen X, Shi X, Yu Z, Ma X. High-intensity interval training in breast cancer patients: A systematic review and meta-analysis. Cancer Med. 2023 Sep;12(17):17692-17705. doi: 10.1002/cam4.6387. Epub 2023 Aug 17.
- Background: PubMed 39342063Castro-Espin C, Cairat M, Navionis AS, Dahm CC, Antoniussen CS, Tjonneland A, Mellemkjaer L, Mancini FR, Hajji-Louati M, Severi G, Le Cornet C, Kaaks R, Schulze MB, Masala G, Agnoli C, Sacerdote C, Crous-Bou M, Sanchez MJ, Amiano P, Chirlaque MD, Guevara M, Smith-Byrne K, Heath AK, Christakoudi S, Gunter MJ, Rinaldi S, Agudo A, Dossus L. Prognostic role of pre-diagnostic circulating inflammatory biomarkers in breast cancer survival: evidence from the EPIC cohort study. Br J Cancer. 2024 Nov;131(9):1496-1505. doi: 10.1038/s41416-024-02858-6. Epub 2024 Sep 28.
- Background: PubMed 31018921Ligibel JA, Dillon D, Giobbie-Hurder A, McTiernan A, Frank E, Cornwell M, Pun M, Campbell N, Dowling RJO, Chang MC, Tolaney S, Chagpar AB, Yung RL, Freedman RA, Dominici LS, Golshan M, Rhei E, Taneja K, Huang Y, Brown M, Winer EP, Jeselsohn R, Irwin ML. Impact of a Pre-Operative Exercise Intervention on Breast Cancer Proliferation and Gene Expression: Results from the Pre-Operative Health and Body (PreHAB) Study. Clin Cancer Res. 2019 Sep 1;25(17):5398-5406. doi: 10.1158/1078-0432.CCR-18-3143. Epub 2019 Apr 24.
- Background: PubMed 33072603Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020.
- Background: PubMed 38642726Del Bianco N, Borsati A, Toniolo L, Ciurnielli C, Belluomini L, Insolda J, Sposito M, Milella M, Schena F, Pilotto S, Avancini A. What is the role of physical exercise in the era of cancer prehabilitation? A systematic review. Crit Rev Oncol Hematol. 2024 Jun;198:104350. doi: 10.1016/j.critrevonc.2024.104350. Epub 2024 Apr 18.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Santos Lozano, PhD principal investigator
Miguel de Cervantes European University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation: Exercise and nutrition in people with Breast Cancer and Breast Neoplasms, run by European University Miguel de Cervantes at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Santos Lozano, PhD (+34 983001000 ext. 22292, asantos@uemc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (peak oxygen consumption): Direct method (time frame: Baseline; up to 1 week before initiation of systemic therapy; up to 1 week after completion of systemic therapy; up to 1 week before initiation of radiotherapy; and up to 1 week after completion of radiotherapy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467824, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.