Breast CancerNEO-ProgramNCT05297773
Resistance vs. Aerobic Training on Breast Cancer Patients Undergoing Neoadjuvant Treatment
A study testing Aerobic Training Group and Resistance Training Group in people with Breast Cancer, run by Fundacao Champalimaud at 2 sites in Portugal.
Trial summary
A recent consensus study suggested that understanding the impact of exercise on the tumor microenvironment and therapy effectiveness is paramount and should be considered as a research priority. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Aerobic Training Group and Resistance Training Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesPortugal
- Study dates
- 16 Dec 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically breast cancer (stage 0-III); scheduled for neoadjuvant treatment (cohort A - chemotherapy; cohort B - endocrine therapy)
- Women aged ≥ 18 years; nonpregnant
- Do not be involved in any structured exercise program in the past 6 months
- Medical approval to participate in the study
- Willingness to attend exercise sessions
Who cannot join
- Treated for any cancer in the past 5 years (except basal cancer)
- Uncontrolled heart disease (heart failure, uncontrolled coronary heart disease, and uncontrolled hypertension, cardiac disease)
- Diabetes mellitus
- Lung condition (chronic obstructive or restrictive pulmonary disease)
- Psychological disorders (dementia, Alzheimer, and Parkinson Disease)
- Severe disability, or other medical condition that prevents from exercise training
- Alcohol or drugs abuse
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Faculdade de Motricidade Humana - Universidade de Lisboa
Lisbon, Cruz-Quebrada, 1495-751
Fundação Champalimaud
Lisbon, Lisbon District, 1400-038
About this study
Official title: Effects of Resistance vs. Aerobic Training on Ki-67 and Other Health-Related Biomarkers: The NEO-Program, a Randomized Controlled Trial on Breast Cancer Patients Undergoing Neoadjuvant Treatment
A recent consensus study suggested that understanding the impact of exercise on the tumor microenvironment and therapy effectiveness is paramount and should be considered as a research priority. Therefore, the research team intends to address some of the scientific challenges proposed, which represent clear gaps in the current knowledge.
The investigators propose a randomized controlled trial conducted during all neoadjuvant treatment duration that aims to evaluate and compare the effects of two different exercise protocols (aerobic and resistance training) against a relaxation control group on Ki-67% changes as the main outcome in breast cancer patients. Secondary outcomes will be body composition; resting metabolic rate; physical fitness; quality of life, fatigue, depression/anxiety; accelerometry data (physical activity levels, sedentary time); sleep quality; tumor biology (size, hypoxia, and immune profile); glycemic, lipid, and inflammatory profile.
This project will help not only researchers with the design of future exercise intervention protocols but will also help exercise physiologists in the decision-making process when defining training programs. Moreover, the investigators expect that this research program will encourage more cancer patients to exercise. The team expects that patients with breast cancer engaging in structured exercise will show a more marked decrease in Ki-67, tumor size, and hypoxia and increase the tumor-infiltrating lymphocytes (TILs) compared to controls. The investigators anticipate a more noticeable decrease in the preoperative endocrine prognostic index (PEPI) score and in the Residual Breast Cancer (RCB) in both training groups (respectively with hormonal and chemotherapy). Also, frequent declines in physical fitness are expected to be mitigated in exercisers. It is hypothesize that aerobic training will ameliorate cardiorespiratory fitness and fat mass, while the effects of resistance training will be more relevant for muscle strength, muscle mass, and bone health. Both exercise groups will show greater improvements in quality of life, fatigue, depression, anxiety, and sleep quality. Regarding glycemic, lipid, and inflammatory profiles, the investigators expect to see more favorable changes in both training groups, with a more evident decrease in fasting glucose and insulin, HbA1c%, total and LDL-cholesterol, and triglycerides, and the increase in HDL-cholesterol. The increase in C-reactive protein (CRP), tumor necrosis factor -α (TNF-α), interleukin-6 (IL-6), IL-8, IL-1β, IL-1ra, and insulin-like growth factor-1 (IGF-1) and the decrease in brain-derived neutrotophic factor (BDNF), IL-12p70, IL-10, oncostatin M will be smaller in exercise groups.
Read the detailed description
Exercise plays a crucial role in breast cancer prevention and more recently it appears as a safe, non-pharmacological, and cost-effective adjuvant therapy for cancer. Indeed exercise improves the quality of life, fatigue, physical fitness, and also has a positive impact on tumor intrinsic characteristics.
Most of the studies regarding the effects of exercise in breast cancer patients were performed after surgery or in survivors. Despite being a window of opportunity to study the impact of exercise on biological properties of the tumor, namely on proliferation markers, the investigations conducted during the neoadjuvant period are still scarce and most of the literature derives from animal studies. Although originating from pilot investigations, the initial human-based evidence suggests that exercise interventions are feasible during neoadjuvant therapy and can potentially reduce some proliferation markers such as Ki-67 (i.e. a widely used prognostic marker), induce favorable changes in tumor-related genes, and increase survival.
Power and sample calculations (G-Power, Version 3.1.9.2) are based on an effect size of 0.25 for KI-67 while using ANOVA - repeated measures within-between interactions, a power of 0.80, a significance of 0.05, and an expected dropout of 40%. The calculation yielded a total sample size of 120 participants (60 undergoing chemotherapy and 60 undergoing hormone therapy: 20 participants per group per each treatment). The power and sample calculations were performed using a study that reported the effect of medication on KI-67 since no study has evaluated the effects of an exercise intervention on that variable and has obtained significant results.
Participants will be recruited to take part in an intervention study for breast cancer patients undergoing neoadjuvant treatment. The recruitment will take place at Champalimaud Clinical Center Breast Unit / Champalimaud Foundation.
To improve exercise adherence, the following strategies will be implemented:
- Thematic sessions about several topics such as physical activity (PA) guidelines, active lifestyle, nutrition, the benefits of exercise for breast cancer patients, etc. Each session will last 1-hour (30 minutes presentation + 30 minutes discussion/questions) and will occur once a month. These thematic sessions are mandatory.
- Group activities: once a month, a group activity will be promoted (exercise outdoor sessions, group walk, group dinner, etc.). In these group activities, participants may invite family members to participate.
- The NEO-program website presenting the mission/goals, team members, activities, news and events, contacts, etc.
- Facebook and Instagram account (share information and photos); before the intervention, written consent for image collection will be requested.
The investigator records clinical data, using a paper or electronic case report form (CRF), all data is collected in an online database that is available through the Champalimaud Clinical Center intranet. Participating physicians have a personal account to log in to the registration page and access the electronic CRF. They will have permanent access to their series of patients.
The participating physician ensures the confidentiality, accuracy, completeness, legibility, and timeliness of the data recorded. Data handling and statistical analysis will be done anonymously by the investigator, with the subject identification code list only available to the local investigator (and research nurse if applicable) working in the local center. The code will be based on the birth date and center abbreviation (and not patient initials). The Sponsor will be the owner of the data. Data will be kept for 20 years.
The Participating Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study.
The collection, processing, and disclosure of personal data, such as patient health and medical information are subject to compliance with applicable personal data protection and the processing of personal data legislation (including but not limited to the European Union Directive 95/46/EC).
Champalimaud Foundation takes out the appropriate insurance.
- Conditions
- Breast Cancer
- Being tested
- Aerobic Training Group, Resistance Training Group, Control group
- Keywords
- Exercise, Quality of life, Neoadjuvant treatment, Tumor biology, Physical fitness, Sleep quality
- Medical subject headings
- Breast Neoplasms, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Training GroupBehavioural
Also called AT, moderate continuous cycling
The participants will perform continuous cycling at 30%-35% of their heart rate reserve for one month (phase 1: adaptive phase). Then, the intensity will increase every 4-5 weeks (± 5%) up to 80% of heart rate reserve (moderate intensity), depending on the participant's tolerance. An individualized equation establishing the relationship between heart rate, oxygen consumption, and power output will be determined during the cardiorespiratory fitness assessment and used to determine exercise intensity.
Resistance Training GroupBehavioural
Also called RT, machine-weight training
Initially, and during the first two weeks of the adaptive phase (1-month), the resistance training group will perform one set of 8-12 repetitions (40%-repetition maximum) of 8 exercises for upper and lower body (squat, leg extension, leg curl, deadlift, plank, dead bug, seated row, shoulder press). Then, in the last two weeks, the participants will perform 2 sets of each exercise (45%-repetition maximum). After the adaptive phase, three sets of each exercise will be performed. The initial load will be 50% -repetition maximum increasing up to a maximum of 70%-repetition maximum at the end of the study. Every 4-5 weeks the load will be reviewed and adjusted according to individual.
Control groupOther
Also called Relaxation/stretching group
The control group will perform a weekly stretching/relaxation session for 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training | Experimental | Three sessions per week during 4-6-months according to each individual treatment plan. Participants allocated in this group will perform moderate-to-vigorous intensity cycling exercise. Receives: Behavioral: Aerobic Training Group |
| Resistance training | Experimental | Three sessions per week during 4-6-months according to each individual treatment plan. Participants allocated in this group will perform weight-machine strength exercises of the upper and lower body. Receives: Behavioral: Resistance Training Group |
| Control Group | Active comparator | One session per week of relaxation/stretching. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline Ki67% at the end of the intervention
Initial tumor biopsy and the post-neoadjuvant surgical specimen will be evaluated. Pathology evaluation will include the Ki67 assessment.
The time frame depends on each participant's treatment plan.
Measured: 4-6 months
Secondary outcomes (12)
Changes in body mass index (BMI) from baseline to T1 and T2
To calculate BMI (kg/m2), Weight and height will be measured on an electronic scale with a stadiometer without shoes wearing minimal clothing to the nearest 0.01 kg/0.1 cm (Seca, Hamburg, Germany). T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Changes in hip circumferences from baseline to T1 and T2
Hip circumference will be taken around the widest portion of the buttocks. Two measurements (to the nearest 0.1 cm) will be performed and a mean value will be calculated. If the two measurements differ by more than 0.5 cm, a third one will be performed and the two closest measurements will be considered.T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Changes in waist circumferences from baseline to T1 and T2
Waist circumference will be assessed according to the NIH (horizontal plane at the level of the iliac crest) and World Health Organization (WHO) protocol (midpoint between the lower margin of the last palpable rib and the top of the iliac crest). Two measurements (to the nearest 0.1 cm) will be performed and a mean value will be calculated. If the two measurements differ by more than 0.5 cm, a third one will be performed and the two closest measurements will be considered.T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Changes in bone mineral density from baseline to T1 and T2
Dual-energy X-ray absorptiometry (GE Lunar Prodigy Primo Hologic, Wisconsin, USA) will be used to estimate bone mineral content/density. T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Changes in lean body mass from baseline to T1 and T2
Dual-energy X-ray absorptiometry (GE Lunar Prodigy Primo Hologic, Wisconsin, USA) will be used to estimate percentage of lean body mass. T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Changes in phase angle from baseline to T1, T2, T3, T4, T5, T6
The participants will undergo bioelectrical impedance analysis (BIA) (single frequency, 50 kilohertz (kHz) ± 1%, NutriLAB, Akern) to determine the PhA and body water compartments (total, extracellular, and intracellular). The participants will be measured in a lying position, with legs apart from each other and arms apart from the trunk, so that the medial surface of the limbs will not touch the rest of the body. Four electrodes (2 in each limb) will be placed on the hand and foot of the dominant side, with a distance of 5 cm between both.
T moments depend on each participant's treatment plan: T1, T2, T3, T4, T5 correspond to 1-, 2-, 3-, 4-, 5-months after the beginning of the intervention, respectively; T6, 6-months (end of the intervention). On those that will undergo a 4-months treatment plan, only T1, T2, T3, and T4 will be performed.
Measured: 4-6 months
Changes in resting metabolic rate from baseline to the end of the intervention
Resting metabolic rate will be measured using indirect calorimetry using a gas analyzer (QUARK resting metabolic rate (RMR) w/ Cardio Pulmonary Exercise Test (CPET), version 9.1, Cosmed, Rome, Italy). The participants will be in a lying position for 30-minutes while using a mask. The first 5-minutes of gas measurement will be discarded. A steady-state period of 5-minutes for oxygen and carbon dioxide volumes (coefficient of variation ≤ 5%) will be used for analyses.
The time frame depends on each participant's treatment plan.
Measured: 4-6 months
Changes in peak oxygen content from baseline to the end of the intervention
Peak oxygen uptake (VO2 peak) will be determined by an incremental supervised CPET performed on a cycle ergometer. The assessment will start at 20 Watts and then the workloads will increase 10 Watts/min. Cadence: 60-70 rpm. All tests will be monitored using a 12-lead electrocardiogram PC-based acquisition module by a certified cardiologist, and heart rate will be recorded using Omnia software. After the calibration, inspired and expired gases will be continuously analyzed through a gas analyzer (QUARK RMR w/CPET, version 9.1, Cosmed, Rome, Italy). Participants will exercise until at least two of the following test termination criteria are reached: (1) volitional fatigue; (2) respiratory exchange ratio reached 1.1 or higher; (3) predicted maximal heart rate; (4) oxygen uptake do not increase despite increasing workload. Peak oxygen will be determined as the highest 20 seconds average of the last minute.
The time frame depends on each participant's treatment plan.
Measured: 4-6 months
Changes from baseline to T1 and T2 in upper limb strength
The handgrip strength test (hydraulic calibrated hand dynamometer - JAMAR) as defined by the American Society of Hand Therapists will be performed to assess upper limb strength. 3 isometric repetitions (separated by 1-minute recovery) will be performed in a seated position. The shoulder joint should be adducted and neutrally rotated; the elbow flexed at 90º, and the forearm in midprone neutral position. The mean of the three trials will be calculated. Verbal encouragement will be provided.
T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Changes from baseline to T1 and T2 in lower limb strength
To evaluate lower limb strength, an isometric mid-thigh pull will be performed while using a force sensor (Chronojump). 3 maximal voluntary repetitions will be performed for 4-5 seconds while receiving a verbal stimulus, with 3 minutes recovery between trials. The bar will be positioned near the thigh and the knees should be positioned at 120º.
T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Change from baseline to T1 and T2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
The EORTC-QLQ-C30 is a 30-item questionnaire composed of 5 multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and 6 single item symptom scales assessing other cancer-related symptoms . The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Change from baseline to T1 and T2 in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning. T1 and T2 depend on each participant's treatment plan: T1, middle of the intervention; T2, end of the intervention.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start16 Dec 2022
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Participants will be followed in a randomized controlled trial conducted during the full duration of neoadjuvant treatment (i.e. 4- to 6-months, depending on patient treatment plan) and two cohorts will be defined: A - breast cancer patients undergoing chemotherapy; B - breast cancer patients undergoing endocrine therapy. Within each cohort, the participants will be divided into three groups: 1) aerobic training; 2): resistance training; 3): control group. The intervention is designed to have equal energy expenditure throughout the exercise sessions in both exercise groups (10 kcal/kg/week). All training groups will complete 3 sessions/week. To ensure that both exercise groups are isoenergetic, a portable gas analyzer will be used and blood lactate will be collected. Mandatory thematic sessions about several topics such as physical activity guidelines, active lifestyle will be implemented.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacao Champalimaud
- Sponsor type
- University, hospital or other
- Collaborators
- Faculdade de Motricidade Humana
- Responsible party
- Principal investigator, Maria-Joao Cardoso, Fundacao Champalimaud
- Investigators
- Inês R. Correia, MSc, Study chair, Faculdade de Motricidade Humana - Universidade de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297773
- Sponsor's protocol ID
- Neo-program 2021.02.23
- Other IDs
- NEO-Program
- Acronym
- NEO-Program
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2022
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance vs. Aerobic Training on Ki-67 and Other Health-Related Biomarkers: The NEO-Program, a Randomized Controlled Trial on Breast Cancer Patients Undergoing Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT05297773
- Acronym / sponsor ID
- NEO-Program / Neo-program 2021.02.23
- Conditions
- Breast Cancer
- Keywords
- Exercise, Quality of life, Neoadjuvant treatment, Tumor biology, Physical fitness, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Fundacao ChampalimaudUniversity, hospital or other
- Collaborators
- Faculdade de Motricidade Humana
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 28 Mar 2022 (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.
A recent consensus study suggested that understanding the impact of exercise on the tumor microenvironment and therapy effectiveness is paramount and should be considered as a research priority. Therefore, the research team intends to address some of the scientific challenges proposed, which represent clear gaps in the current knowledge.
The investigators propose a randomized controlled trial conducted during all neoadjuvant treatment duration that aims to evaluate and compare the effects of two different exercise protocols (aerobic and resistance training) against a relaxation control group on Ki-67% changes as the main outcome in breast cancer patients. Secondary outcomes will be body composition; resting metabolic rate; physical fitness; quality of life, fatigue, depression/anxiety; accelerometry data (physical activity levels, sedentary time); sleep quality; tumor biology (size, hypoxia, and immune profile); glycemic, lipid, and inflammatory profile.
This project will help not only researchers with the design of future exercise intervention protocols but will also help exercise physiologists in the decision-making process when defining training programs. Moreover, the investigators expect that this research program will encourage more cancer patients to exercise. The team expects that patients with breast cancer engaging in structured exercise will show a more marked decrease in Ki-67, tumor size, and hypoxia and increase the tumor-infiltrating lymphocytes (TILs) compared to controls. The investigators anticipate a more noticeable decrease in the preoperative endocrine prognostic index (PEPI) score and in the Residual Breast Cancer (RCB) in both training groups (respectively with hormonal and chemotherapy). Also, frequent declines in physical fitness are expected to be mitigated in exercisers. It is hypothesize that aerobic training will ameliorate cardiorespiratory fitness and fat mass, while the effects of resistance training will be more relevant for muscle strength, muscle mass, and bone health. Both exercise groups will show greater improvements in quality of life, fatigue, depression, anxiety, and sleep quality. Regarding glycemic, lipid, and inflammatory profiles, the investigators expect to see more favorable changes in both training groups, with a more evident decrease in fasting glucose and insulin, HbA1c%, total and LDL-cholesterol, and triglycerides, and the increase in HDL-cholesterol. The increase in C-reactive protein (CRP), tumor necrosis factor -α (TNF-α), interleukin-6 (IL-6), IL-8, IL-1β, IL-1ra, and insulin-like growth factor-1 (IGF-1) and the decrease in brain-derived neutrotophic factor (BDNF), IL-12p70, IL-10, oncostatin M will be smaller in exercise groups.
Detailed description
Exercise plays a crucial role in breast cancer prevention and more recently it appears as a safe, non-pharmacological, and cost-effective adjuvant therapy for cancer. Indeed exercise improves the quality of life, fatigue, physical fitness, and also has a positive impact on tumor intrinsic characteristics.
Most of the studies regarding the effects of exercise in breast cancer patients were performed after surgery or in survivors. Despite being a window of opportunity to study the impact of exercise on biological properties of the tumor, namely on proliferation markers, the investigations conducted during the neoadjuvant period are still scarce and most of the literature derives from animal studies. Although originating from pilot investigations, the initial human-based evidence suggests that exercise interventions are feasible during neoadjuvant therapy and can potentially reduce some proliferation markers such as Ki-67 (i.e. a widely used prognostic marker), induce favorable changes in tumor-related genes, and increase survival.
Power and sample calculations (G-Power, Version 3.1.9.2) are based on an effect size of 0.25 for KI-67 while using ANOVA - repeated measures within-between interactions, a power of 0.80, a significance of 0.05, and an expected dropout of 40%. The calculation yielded a total sample size of 120 participants (60 undergoing chemotherapy and 60 undergoing hormone therapy: 20 participants per group per each treatment). The power and sample calculations were performed using a study that reported the effect of medication on KI-67 since no study has evaluated the effects of an exercise intervention on that variable and has obtained significant results.
Participants will be recruited to take part in an intervention study for breast cancer patients undergoing neoadjuvant treatment. The recruitment will take place at Champalimaud Clinical Center Breast Unit / Champalimaud Foundation.
To improve exercise adherence, the following strategies will be implemented:
- Thematic sessions about several topics such as physical activity (PA) guidelines, active lifestyle, nutrition, the benefits of exercise for breast cancer patients, etc. Each session will last 1-hour (30 minutes presentation + 30 minutes discussion/questions) and will occur once a month. These thematic sessions are mandatory.
- Group activities: once a month, a group activity will be promoted (exercise outdoor sessions, group walk, group dinner, etc.). In these group activities, participants may invite family members to participate.
- The NEO-program website presenting the mission/goals, team members, activities, news and events, contacts, etc.
- Facebook and Instagram account (share information and photos); before the intervention, written consent for image collection will be requested.
The investigator records clinical data, using a paper or electronic case report form (CRF), all data is collected in an online database that is available through the Champalimaud Clinical Center intranet. Participating physicians have a personal account to log in to the registration page and access the electronic CRF. They will have permanent access to their series of patients.
The participating physician ensures the confidentiality, accuracy, completeness, legibility, and timeliness of the data recorded. Data handling and statistical analysis will be done anonymously by the investigator, with the subject identification code list only available to the local investigator (and research nurse if applicable) working in the local center. The code will be based on the birth date and center abbreviation (and not patient initials). The Sponsor will be the owner of the data. Data will be kept for 20 years.
The Participating Investigator and the Participating Site shall treat all information and data relating to the Study disclosed to Participating Site and/or Investigator in this study as confidential and shall not disclose such information to any third parties or use such information for any purpose other than the performance of the Study.
The collection, processing, and disclosure of personal data, such as patient health and medical information are subject to compliance with applicable personal data protection and the processing of personal data legislation (including but not limited to the European Union Directive 95/46/EC).
Champalimaud Foundation takes out the appropriate insurance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be followed in a randomized controlled trial conducted during the full duration of neoadjuvant treatment (i.e. 4- to 6-months, depending on patient treatment plan) and two cohorts will be defined: A - breast cancer patients undergoing chemotherapy; B - breast cancer patients undergoing endocrine therapy. Within each cohort, the participants will be divided into three groups: 1) aerobic training; 2): resistance training; 3): control group. The intervention is designed to have equal energy expenditure throughout the exercise sessions in both exercise groups (10 kcal/kg/week). All training groups will complete 3 sessions/week. To ensure that both exercise groups are isoenergetic, a portable gas analyzer will be used and blood lactate will be collected. Mandatory thematic sessions about several topics such as physical activity guidelines, active lifestyle will be implemented.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training | Experimental | Behavioral: Aerobic Training GroupThree sessions per week during 4-6-months according to each individual treatment plan. Participants allocated in this group will perform moderate-to-vigorous intensity cycling exercise. |
| Resistance training | Experimental | Behavioral: Resistance Training GroupThree sessions per week during 4-6-months according to each individual treatment plan. Participants allocated in this group will perform weight-machine strength exercises of the upper and lower body. |
| Control Group | Active comparator | Other: Control groupOne session per week of relaxation/stretching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically breast cancer (stage 0-III); scheduled for neoadjuvant treatment (cohort A - chemotherapy; cohort B - endocrine therapy)
- Women aged ≥ 18 years; nonpregnant
- Do not be involved in any structured exercise program in the past 6 months
- Medical approval to participate in the study
- Willingness to attend exercise sessions
Key exclusion criteria (7 listed)
- Treated for any cancer in the past 5 years (except basal cancer)
- Uncontrolled heart disease (heart failure, uncontrolled coronary heart disease, and uncontrolled hypertension, cardiac disease)
- Diabetes mellitus
- Lung condition (chronic obstructive or restrictive pulmonary disease)
- Psychological disorders (dementia, Alzheimer, and Parkinson Disease)
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 |
|---|---|---|
| Aerobic Training GroupAlso: AT, moderate continuous cyclingThe participants will perform continuous cycling at 30%-35% of their heart rate reserve for one month (phase 1: adaptive phase). Then, the intensity will increase every 4-5 weeks (± 5%) up to 80% of heart rate reserve (moderate intensity), depending on the participant's tolerance. An individualized equation establishing the relationship between heart rate, oxygen consumption, and power output will be determined during the cardiorespiratory fitness assessment and used to determine exercise intensity. | Behavioural | Aerobic Training |
| Resistance Training GroupAlso: RT, machine-weight trainingInitially, and during the first two weeks of the adaptive phase (1-month), the resistance training group will perform one set of 8-12 repetitions (40%-repetition maximum) of 8 exercises for upper and lower body (squat, leg extension, leg curl, deadlift, plank, dead bug, seated row, shoulder press). Then, in the last two weeks, the participants will perform 2 sets of each exercise (45%-repetition maximum). After the adaptive phase, three sets of each exercise will be performed. The initial load will be 50% -repetition maximum increasing up to a maximum of 70%-repetition maximum at the end of the study. Every 4-5 weeks the load will be reviewed and adjusted according to individual. | Behavioural | Resistance training |
| Control groupAlso: Relaxation/stretching groupThe control group will perform a weekly stretching/relaxation session for 45 minutes. | Other | Control Group |
Primary outcome
Changes from baseline Ki67% at the end of the intervention
Time frame: 4-6 months
Initial tumor biopsy and the post-neoadjuvant surgical specimen will be evaluated. Pathology evaluation will include the Ki67 assessment. The time frame depends on each participant's treatment plan.
12 secondary outcomes
Changes in body mass index (BMI) from baseline to T1 and T2
Time frame: 4-6 months
Changes in hip circumferences from baseline to T1 and T2
Time frame: 4-6 months
Changes in waist circumferences from baseline to T1 and T2
Time frame: 4-6 months
Changes in bone mineral density from baseline to T1 and T2
Time frame: 4-6 months
Changes in lean body mass from baseline to T1 and T2
Time frame: 4-6 months
Changes in phase angle from baseline to T1, T2, T3, T4, T5, T6
Time frame: 4-6 months
Changes in resting metabolic rate from baseline to the end of the intervention
Time frame: 4-6 months
Changes in peak oxygen content from baseline to the end of the intervention
Time frame: 4-6 months
Changes from baseline to T1 and T2 in upper limb strength
Time frame: 4-6 months
Changes from baseline to T1 and T2 in lower limb strength
Time frame: 4-6 months
Change from baseline to T1 and T2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
Time frame: 4-6 months
Change from baseline to T1 and T2 in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
Time frame: 4-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Inês R. Correia, MSc study chair
Faculdade de Motricidade Humana - Universidade de Lisboa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training Group and Resistance Training Group in people with Breast Cancer, run by Fundacao Champalimaud at 2 sites in Portugal.
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 7 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: finished, as of the sponsor's last update on 23 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline Ki67% at the end of the intervention (time frame: 4-6 months). 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 NCT05297773, which also lists 1 linked publication.
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 23 Jun 2026.