Breast CancerPREDUNCT07502963
Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer
A study testing PREDU Exercise Program and Recommendation Exercise Program in people with Breast Cancer and Lung Cancer (Non-Small Cell), run by University of Vic - Central University of Catalonia at 3 sites in Spain.
Trial summary
This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer
- What is being tested?
- PREDU Exercise Program and Recommendation Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesSpain
- Study dates
- Apr 2026to Oct 2027
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and men aged 35 to 65 years
- Diagnosed with stage II, III, or IV breast, lung, or colon cancer
- Scheduled to start neoadjuvant chemotherapy
- Able and willing to provide written informed consent
Who cannot join
- Musculoskeletal or neurological disorders that prevent proper execution of the exercises
- Uncontrolled infections or symptoms
- Comorbidities such as chronic obstructive pulmonary disease (COPD), respiratory failure, or recent cardiovascular events within the past 6 months
- Body mass index (BMI) over 35
- Pregnant women
- Difficulty understanding the purpose and procedures of the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Consorci Hospitalari de Vic
Vic, Barcelona, 08500
(+34) 93 889 11 11
Facultat de Ciències de la Salut i del Benestar de la Universitat de Vic (UVIC-UCC) Universitat de Vic- Universitat Central de Catalunya
Vic, Barcelona, 08500
Meritxell Parareda Ventura, (+34) 93 881 60 25, meritxell.parareda@uvic.cat
Hospital Universitari de la Santa Creu
Vic, Barcelona, 08500
Josep Ortiz, (+34) 93 883 33 00, meritxell.parareda@uvic.cat
About this study
Official title: Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer: Randomized Clinical Trial.
This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer.
The study hypothesis is that participation in this exercise program improves tolerance to chemotherapy, allowing patients to receive more than 85% of the planned relative dose intensity. In addition, the program is expected to enhance treatment effectiveness by increasing the rate of complete radiological response.
The main objective of the study is to assess the effectiveness of a supervised, multimodal therapeutic exercise program performed before and during chemotherapy in improving both treatment tolerance and treatment efficacy in patients with breast, lung, and colon cancer.
Read the detailed description
This study proposes a randomized, stratified, assessor-blinded, longitudinal, prospective clinical trial designed in accordance with the CONSORT guidelines.
This study is justified by the need to identify effective strategies to improve chemotherapy tolerance and efficacy, as well as to reduce adverse effects and preserve patients' quality of life. The available scientific evidence suggests that multimodal physical activity programs combining cardiovascular and strength training, particularly when supervised, individualized, initiated before treatment, and maintained throughout chemotherapy, may exert a positive impact on chemotherapy tolerance and efficacy. These variables are key determinants in achieving favorable indicators and in improving the side effects caused by chemotherapy.
OBJECTIVES AND HYPOTHESIS The primary objective is to evaluate the effectiveness of a supervised multimodal therapeutic exercise program, initiated before and maintained during chemotherapy, on treatment tolerance and efficacy in patients aged 35 to 65 years diagnosed with breast, lung, or colorectal cancer.
The following outcomes will be compared between the experimental and control groups:
- Relative Dose Intensity (RDI)
- Treatment completion rate
- Radiological or pathological complete response
Secondary objectives include comparing the evolution of cancer-related fatigue, quality of life, muscular strength, cardiorespiratory capacity, and adherence to physical activity between both groups. Additionally, the study will explore whether tumor location, cancer stage, and age moderate the effect of the intervention on treatment tolerance and efficacy, as well as on secondary outcomes.
The main hypothesis is that participants performing supervised therapeutic exercise will more frequently achieve an RDI ≥85% compared to the control group and will demonstrate improved therapeutic efficacy outcomes.
STUDY DESIGN
Two parallel groups will be included:
Experimental Group (EG): supervised therapeutic exercise program Control Group (CG): unsupervised home-based physical activity with general recommendations
Randomization will be stratified according to cancer location (breast, lung, or colorectal) to ensure balance between groups. Allocation will be generated using computer software. Outcome assessors will be blinded to group assignment.
INTERVENTION
The total duration of the program will be 48 weeks, including 18 weeks of active intervention during chemotherapy and 24 weeks of follow-up after treatment completion.
CONTROL GROUP
Participants in the control group will receive standardized verbal and written recommendations to perform therapeutic physical activity at home in accordance with World Health Organization guidelines.
Recommendations will include:
3-4 weekly sessions of aerobic exercise (30-45 minutes at approximately 70% of maximum heart rate), such as walking, brisk walking, cycling, swimming, or rowing.
2 weekly strength-training sessions (approximately 30 minutes), including upper limb, trunk, and lower limb exercises at intensities between 50-80% of one-repetition maximum (1RM), consisting of 2 sets of 8-12 repetitions, using body weight and elastic resistance bands.
Low-intensity joint mobility exercises. These activities will not be supervised or individualized by the research team.
EXPERIMENTAL GROUP
Participants in the experimental group will perform supervised and individualized therapeutic exercise sessions in specialized centers. The program will be adapted according to fatigue levels and the phase of the chemotherapy cycle.
Three supervised sessions per week will be conducted:
One session focused on aerobic exercise (45 minutes), combining moderate continuous training (approximately 70% of maximum heart rate) with moderate interval training (>85% of maximum heart rate alternating with 50% of maximum heart rate), including Low-Intensity High-Intensity Interval Training (Low HIIT).
Two combined sessions (50 minutes each), including:
30 minutes of aerobic exercise 20 minutes of strength training at intensities between 50-80% of 1RM, 2 sets of 8-12 repetitions, using guided machines, elastic resistance bands, and free weights.
Exercises will target the main muscle groups (quadriceps, hamstrings, gluteal muscles, pectoralis major, latissimus dorsi, biceps, triceps, and lumbar musculature). All sessions will include low-intensity joint mobility exercises.
PROCEDURE AND ASSESSMENTS
Four assessment time points will be conducted:
Baseline (at diagnosis) At the start of chemotherapy At completion of chemotherapy At 24 weeks after completion of the intervention
The general areas assessed will include:
Relative Dose Intensity (RDI) Radiological complete response (RRC) Dynamic and static muscular strength Cardiorespiratory capacity Cancer-related fatigue Quality of life Adherence to physical activity
- Conditions
- Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer, Physical Activity, Neoadjuvant Chemotherapy Tolerance, Strength and Endurance
- Being tested
- PREDU Exercise Program, Recommendation Exercise Program
- Keywords
- Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal cancer, Physical Activity, Strength and endurance, Neoadjuvant Chemotherapy Tolerance
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREDU Exercise ProgramOther
The intervention includes a supervised, multimodal therapeutic exercise program in two phases: 2 weeks before chemotherapy and 16 weeks during chemotherapy.
Pre-chemotherapy (2 weeks): 3 weekly home-based aerobic sessions and 2 supervised strength sessions (30 min each) using free weights or guided equipment.
During chemotherapy (16 weeks): 3 supervised sessions per week combining aerobic and strength training (20-50 min each). Aerobic exercises use stationary cycling or treadmill moderate continuous (70% HRmax) and interval training (Low HIIT 85%HRmax). Strength exercises are 2 sets of 8-12 reps at 50-80% of 1RM, using guided weights and elastic bands.
The program is adapted and planned according to participants' fatigue and chemotherapy cycle.
Recommendation Exercise ProgramOther
Participants follow unsupervised exercise recommendations during the 2 weeks before and the 16 weeks of chemotherapy. Aerobic exercises are 30-45 minutes, 3-4 times per week (walking, swimming, cycling), and strength exercises are 2 sessions per week, 30 minutes each, targeting upper limbs, trunk, and lower limbs. Participants are responsible for following these recommendations on their own, without individualized adaptation or supervision, aiming to meet WHO exercise guidelines for oncology populations.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | An exercise program based on guidance provided during the informational session and the provided brochure is followed, without planning, adaptation, or supervision. Recommendations include aerobic and strength training exercises. Receives: Other: Recommendation Exercise Program |
| Experimental group | Experimental | A supervised, planned, and adapted therapeutic physical exercise program is implemented according to fatigue levels and the phase of the neoadjuvant chemotherapy cycle. The program includes three supervised sessions per week combining aerobic and strength training exercises. Receives: Other: PREDU Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI)
Percentage of relative dose intensity (RDI), calculated as the ratio between planned chemotherapy dose and administered dose, expressed as a percentage. Data are obtained from medical clinical records. Compare the results between the groups.
Measured: Evaluation at the start of chemotherapy (2 weeks after the beginning of the PREDU intervention) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Complete Response (CR) Rate according to RECIST 1.1 Criteria
Percentage of participants achieving complete response (CR), defined as the disappearance of all target lesions and reduction of pathological lymph nodes to <10 mm, assessed using the RECIST 1.1 criteria scale. Data are obtained from medical clinical records. Compare the results between the groups.
Measured: CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Secondary outcomes (8)
Cancer-Related Fatigue Score assessed by Piper Fatigue Scale
Fatigue is measured using the Piper Fatigue Scale, a self-reported instrument with 22 items scored from 0 to 10, where higher scores indicate greater fatigue. The scale evaluates four dimensions of subjective fatigue: severity, sensory impact, cognitive impact, and mood. The total fatigue score is calculated by summing the scores of the four dimensions and dividing by four. Measured on a numerical scale from 0 to 10. Compare the results of the four assessments and between the groups.
Measured: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Static muscle strenght (kg) assessed by Handheld Dynamometer
Peak muscle strength, expressed in kilograms (kg), assessed using a handheld dynamometer. Comparisons are made across all four assessments and between the groups.
Measured: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Dynamic Muscle Strength (kg) using Brzycki Equation
Estimated dynamic muscle strength, expressed in kilograms (kg), calculated from n-repetition maximum (n-RM) using the Brzycki equation.
Measured: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Change in Quality of Life Score
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are on a 0-100 scale, with higher scores indicating better functioning or quality of life, whereas for symptom scales, higher scores indicate greater symptom burden. Compare the results of the four assessments and between the groups.
Measured: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Change in Cardiorespiratory Capacity
Cardiorespiratory capacity is assessed using the 6-Minute Walk Test (6MWT), a submaximal field test in which participants walk the greatest distance possible in 6 minutes along a 30-meter flat course. Exercise tolerance is evaluated through the distance walked (meters) and estimated VO₂max. Higher values indicate better cardiorespiratory fitness. Assessments are conducted at all four time points, and results are compared between the groups.
Measured: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of Participants in Each Stage of Change Physical Activity Adherence
Percentage of participants in each stage of change for physical activity, assessed using the Transtheoretical Model. Data are collected at each assessment point and compared between the control and experimental groups.
Measured: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of Participants by Physical Activity Adherence Level
Percentage of participants achieving each level of moderate and vigorous physical activity (minutes per week), assessed and compared between the control and experimental groups to evaluate changes in adherence to physical activity.
Measured: Assessed at baseline and at 24 weeks after completion of the intervention.
To explore whether tumor location, stage, and age moderate the effect of the intervention on treatment tolerance and efficacy
Compare the primary and secondary outcome results by tumor location, stage, and age to explore whether outcomes differ between these subgroups.
Measured: Assessments are conducted from the first evaluation up to the third evaluation at 18 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- A randomized clinical trial with blinded outcomes assessor, longitudinal and prospective design is proposed, in accordance with the CONSORT 2025 guidelines.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Col·legi Fisioterapeutes de Catalunya
- Responsible party
- Principal investigator, Meritxell Parareda, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502963
- Sponsor's protocol ID
- PREDU
- Acronym
- PREDU
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416.
PubMed 40788186Schmidt ME, Goldschmidt S, Kreutz C, Muller J, Schneeweiss A, May AM, Rosenberger F, Wiskemann J, Steindorf K. Effects of aerobic or resistance exercise during neoadjuvant chemotherapy on tumor response and therapy completion in women with breast cancer: The randomized controlled BENEFIT trial. J Sport Health Sci. 2025 Dec;14:101064. doi: 10.1016/j.jshs.2025.101064. Epub 2025 May 28.
PubMed 40447136Ormel HL, van der Schoot GGF, Sluiter WJ, Jalving M, Gietema JA, Walenkamp AME. Predictors of adherence to exercise interventions during and after cancer treatment: A systematic review. Psychooncology. 2018 Mar;27(3):713-724. doi: 10.1002/pon.4612. Epub 2018 Jan 26.
PubMed 29247584But-Hadzic J, Dervisevic M, Karpljuk D, Videmsek M, Dervisevic E, Paravlic A, Hadzic V, Tomazin K. Six-Minute Walk Distance in Breast Cancer Survivors-A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2021 Mar 5;18(5):2591. doi: 10.3390/ijerph18052591.
PubMed 33807611van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.
PubMed 36444224Groen WG, Naaktgeboren WR, van Harten WH, van Vulpen JK, Kool N, Sonke GS, van der Wall E, Velthuis MJ, Aaronson NK, May AM, Stuiver MM. Physical Fitness and Chemotherapy Tolerance in Patients with Early-Stage Breast Cancer. Med Sci Sports Exerc. 2022 Apr 1;54(4):537-542. doi: 10.1249/MSS.0000000000002828.
PubMed 34961754Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
PubMed 31626055Ficarra S, Thomas E, Bianco A, Gentile A, Thaller P, Grassadonio F, Papakonstantinou S, Schulz T, Olson N, Martin A, Wagner C, Nordstrom A, Hofmann H. Impact of exercise interventions on physical fitness in breast cancer patients and survivors: a systematic review. Breast Cancer. 2022 May;29(3):402-418. doi: 10.1007/s12282-022-01347-z. Epub 2022 Mar 12.
PubMed 35278203Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17.
PubMed 35715631Lin D, Sturgeon KM, Muscat JE, Zhou S, Hobkirk AL, O'Brien KM, Sandler DP, Thompson CL. Associations of pre-diagnosis physical activity with treatment tolerance and treatment efficacy in breast cancer patients with neoadjuvant chemotherapy. Breast Cancer. 2024 May;31(3):519-528. doi: 10.1007/s12282-024-01569-3. Epub 2024 Apr 2.
PubMed 38564089Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26.
PubMed 31877085Koelwyn GJ, Quail DF, Zhang X, White RM, Jones LW. Exercise-dependent regulation of the tumour microenvironment. Nat Rev Cancer. 2017 Sep 25;17(10):620-632. doi: 10.1038/nrc.2017.78.
PubMed 28943640Christianson JB, Wholey DR, Sanchez SM. State responses to HMO failures. Health Aff (Millwood). 1991 Winter;10(4):78-92. doi: 10.1377/hlthaff.10.4.78. No abstract available.
PubMed 1778570Montano-Rojas LS, Romero-Perez EM, Medina-Perez C, Reguera-Garcia MM, de Paz JA. Resistance Training in Breast Cancer Survivors: A Systematic Review of Exercise Programs. Int J Environ Res Public Health. 2020 Sep 7;17(18):6511. doi: 10.3390/ijerph17186511.
PubMed 32906761Juvet LK, Thune I, Elvsaas IKO, Fors EA, Lundgren S, Bertheussen G, Leivseth G, Oldervoll LM. The effect of exercise on fatigue and physical functioning in breast cancer patients during and after treatment and at 6 months follow-up: A meta-analysis. Breast. 2017 Jun;33:166-177. doi: 10.1016/j.breast.2017.04.003. Epub 2017 Apr 14.
PubMed 28415013
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07502963
- Acronym / sponsor ID
- PREDU / PREDU
- Conditions
- Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer, Physical Activity, Neoadjuvant Chemotherapy Tolerance, Strength and Endurance
- Keywords
- Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal cancer, Physical Activity, Strength and endurance, Neoadjuvant Chemotherapy Tolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Col·legi Fisioterapeutes de Catalunya
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 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.
This clinical study evaluates whether a supervised, multimodal therapeutic exercise program started before chemotherapy and continued during treatment can improve treatment outcomes in patients aged 35 to 65 years with breast, lung, or colon cancer.
The study hypothesis is that participation in this exercise program improves tolerance to chemotherapy, allowing patients to receive more than 85% of the planned relative dose intensity. In addition, the program is expected to enhance treatment effectiveness by increasing the rate of complete radiological response.
The main objective of the study is to assess the effectiveness of a supervised, multimodal therapeutic exercise program performed before and during chemotherapy in improving both treatment tolerance and treatment efficacy in patients with breast, lung, and colon cancer.
Detailed description
This study proposes a randomized, stratified, assessor-blinded, longitudinal, prospective clinical trial designed in accordance with the CONSORT guidelines.
This study is justified by the need to identify effective strategies to improve chemotherapy tolerance and efficacy, as well as to reduce adverse effects and preserve patients' quality of life. The available scientific evidence suggests that multimodal physical activity programs combining cardiovascular and strength training, particularly when supervised, individualized, initiated before treatment, and maintained throughout chemotherapy, may exert a positive impact on chemotherapy tolerance and efficacy. These variables are key determinants in achieving favorable indicators and in improving the side effects caused by chemotherapy.
OBJECTIVES AND HYPOTHESIS The primary objective is to evaluate the effectiveness of a supervised multimodal therapeutic exercise program, initiated before and maintained during chemotherapy, on treatment tolerance and efficacy in patients aged 35 to 65 years diagnosed with breast, lung, or colorectal cancer.
The following outcomes will be compared between the experimental and control groups:
- Relative Dose Intensity (RDI)
- Treatment completion rate
- Radiological or pathological complete response
Secondary objectives include comparing the evolution of cancer-related fatigue, quality of life, muscular strength, cardiorespiratory capacity, and adherence to physical activity between both groups. Additionally, the study will explore whether tumor location, cancer stage, and age moderate the effect of the intervention on treatment tolerance and efficacy, as well as on secondary outcomes.
The main hypothesis is that participants performing supervised therapeutic exercise will more frequently achieve an RDI ≥85% compared to the control group and will demonstrate improved therapeutic efficacy outcomes.
STUDY DESIGN
Two parallel groups will be included:
Experimental Group (EG): supervised therapeutic exercise program Control Group (CG): unsupervised home-based physical activity with general recommendations
Randomization will be stratified according to cancer location (breast, lung, or colorectal) to ensure balance between groups. Allocation will be generated using computer software. Outcome assessors will be blinded to group assignment.
INTERVENTION
The total duration of the program will be 48 weeks, including 18 weeks of active intervention during chemotherapy and 24 weeks of follow-up after treatment completion.
CONTROL GROUP
Participants in the control group will receive standardized verbal and written recommendations to perform therapeutic physical activity at home in accordance with World Health Organization guidelines.
Recommendations will include:
3-4 weekly sessions of aerobic exercise (30-45 minutes at approximately 70% of maximum heart rate), such as walking, brisk walking, cycling, swimming, or rowing.
2 weekly strength-training sessions (approximately 30 minutes), including upper limb, trunk, and lower limb exercises at intensities between 50-80% of one-repetition maximum (1RM), consisting of 2 sets of 8-12 repetitions, using body weight and elastic resistance bands.
Low-intensity joint mobility exercises. These activities will not be supervised or individualized by the research team.
EXPERIMENTAL GROUP
Participants in the experimental group will perform supervised and individualized therapeutic exercise sessions in specialized centers. The program will be adapted according to fatigue levels and the phase of the chemotherapy cycle.
Three supervised sessions per week will be conducted:
One session focused on aerobic exercise (45 minutes), combining moderate continuous training (approximately 70% of maximum heart rate) with moderate interval training (>85% of maximum heart rate alternating with 50% of maximum heart rate), including Low-Intensity High-Intensity Interval Training (Low HIIT).
Two combined sessions (50 minutes each), including:
30 minutes of aerobic exercise 20 minutes of strength training at intensities between 50-80% of 1RM, 2 sets of 8-12 repetitions, using guided machines, elastic resistance bands, and free weights.
Exercises will target the main muscle groups (quadriceps, hamstrings, gluteal muscles, pectoralis major, latissimus dorsi, biceps, triceps, and lumbar musculature). All sessions will include low-intensity joint mobility exercises.
PROCEDURE AND ASSESSMENTS
Four assessment time points will be conducted:
Baseline (at diagnosis) At the start of chemotherapy At completion of chemotherapy At 24 weeks after completion of the intervention
The general areas assessed will include:
Relative Dose Intensity (RDI) Radiological complete response (RRC) Dynamic and static muscular strength Cardiorespiratory capacity Cancer-related fatigue Quality of life Adherence to physical activity
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized clinical trial with blinded outcomes assessor, longitudinal and prospective design is proposed, in accordance with the CONSORT 2025 guidelines.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Recommendation Exercise ProgramAn exercise program based on guidance provided during the informational session and the provided brochure is followed, without planning, adaptation, or supervision. Recommendations include aerobic and strength training exercises. |
| Experimental group | Experimental | Other: PREDU Exercise ProgramA supervised, planned, and adapted therapeutic physical exercise program is implemented according to fatigue levels and the phase of the neoadjuvant chemotherapy cycle. The program includes three supervised sessions per week combining aerobic and strength training exercises. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women and men aged 35 to 65 years
- Diagnosed with stage II, III, or IV breast, lung, or colon cancer
- Scheduled to start neoadjuvant chemotherapy
- Able and willing to provide written informed consent
Key exclusion criteria (6 listed)
- Musculoskeletal or neurological disorders that prevent proper execution of the exercises
- Uncontrolled infections or symptoms
- Comorbidities such as chronic obstructive pulmonary disease (COPD), respiratory failure, or recent cardiovascular events within the past 6 months
- Body mass index (BMI) over 35
- Pregnant women
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 |
|---|---|---|
| PREDU Exercise ProgramThe intervention includes a supervised, multimodal therapeutic exercise program in two phases: 2 weeks before chemotherapy and 16 weeks during chemotherapy. Pre-chemotherapy (2 weeks): 3 weekly home-based aerobic sessions and 2 supervised strength sessions (30 min each) using free weights or guided equipment. During chemotherapy (16 weeks): 3 supervised sessions per week combining aerobic and strength training (20-50 min each). Aerobic exercises use stationary cycling or treadmill moderate continuous (70% HRmax) and interval training (Low HIIT 85%HRmax). Strength exercises are 2 sets of 8-12 reps at 50-80% of 1RM, using guided weights and elastic bands. The program is adapted and planned according to participants' fatigue and chemotherapy cycle. | Other | Experimental group |
| Recommendation Exercise ProgramParticipants follow unsupervised exercise recommendations during the 2 weeks before and the 16 weeks of chemotherapy. Aerobic exercises are 30-45 minutes, 3-4 times per week (walking, swimming, cycling), and strength exercises are 2 sessions per week, 30 minutes each, targeting upper limbs, trunk, and lower limbs. Participants are responsible for following these recommendations on their own, without individualized adaptation or supervision, aiming to meet WHO exercise guidelines for oncology populations. | Other | Control group |
Primary outcome
Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI)
Time frame: Evaluation at the start of chemotherapy (2 weeks after the beginning of the PREDU intervention) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Percentage of relative dose intensity (RDI), calculated as the ratio between planned chemotherapy dose and administered dose, expressed as a percentage. Data are obtained from medical clinical records. Compare the results between the groups.
Complete Response (CR) Rate according to RECIST 1.1 Criteria
Time frame: CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Percentage of participants achieving complete response (CR), defined as the disappearance of all target lesions and reduction of pathological lymph nodes to <10 mm, assessed using the RECIST 1.1 criteria scale. Data are obtained from medical clinical records. Compare the results between the groups.
8 secondary outcomes
Cancer-Related Fatigue Score assessed by Piper Fatigue Scale
Time frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Static muscle strenght (kg) assessed by Handheld Dynamometer
Time frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Dynamic Muscle Strength (kg) using Brzycki Equation
Time frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Change in Quality of Life Score
Time frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Change in Cardiorespiratory Capacity
Time frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of Participants in Each Stage of Change Physical Activity Adherence
Time frame: Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.
Percentage of Participants by Physical Activity Adherence Level
Time frame: Assessed at baseline and at 24 weeks after completion of the intervention.
To explore whether tumor location, stage, and age moderate the effect of the intervention on treatment tolerance and efficacy
Time frame: Assessments are conducted from the first evaluation up to the third evaluation at 18 weeks.
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 31 Mar 2026.
- Background: PubMed 40788186Kjeldsted E, Ammitzboll G, Laenkholm AV, Rasic D, Ceballos SG, Jorgensen LB, Skou ST, Bojesen RD, Lodin A, Tolver A, Rosthoj S, Jack S, Gehl J, Dalton SO. Effects of Supervised Exercise during Neoadjuvant Chemotherapy on Tumor Response in Patients with Breast Cancer (Neo-train): A Randomized Controlled Trial. Clin Cancer Res. 2025 Oct 15;31(20):4265-4277. doi: 10.1158/1078-0432.CCR-25-0416.
- Background: PubMed 40447136Schmidt ME, Goldschmidt S, Kreutz C, Muller J, Schneeweiss A, May AM, Rosenberger F, Wiskemann J, Steindorf K. Effects of aerobic or resistance exercise during neoadjuvant chemotherapy on tumor response and therapy completion in women with breast cancer: The randomized controlled BENEFIT trial. J Sport Health Sci. 2025 Dec;14:101064. doi: 10.1016/j.jshs.2025.101064. Epub 2025 May 28.
- Background: PubMed 29247584Ormel HL, van der Schoot GGF, Sluiter WJ, Jalving M, Gietema JA, Walenkamp AME. Predictors of adherence to exercise interventions during and after cancer treatment: A systematic review. Psychooncology. 2018 Mar;27(3):713-724. doi: 10.1002/pon.4612. Epub 2018 Jan 26.
- Background: PubMed 33807611But-Hadzic J, Dervisevic M, Karpljuk D, Videmsek M, Dervisevic E, Paravlic A, Hadzic V, Tomazin K. Six-Minute Walk Distance in Breast Cancer Survivors-A Systematic Review with Meta-Analysis. Int J Environ Res Public Health. 2021 Mar 5;18(5):2591. doi: 10.3390/ijerph18052591.
- Background: PubMed 36444224van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.
- Background: PubMed 34961754Groen WG, Naaktgeboren WR, van Harten WH, van Vulpen JK, Kool N, Sonke GS, van der Wall E, Velthuis MJ, Aaronson NK, May AM, Stuiver MM. Physical Fitness and Chemotherapy Tolerance in Patients with Early-Stage Breast Cancer. Med Sci Sports Exerc. 2022 Apr 1;54(4):537-542. doi: 10.1249/MSS.0000000000002828.
- Background: PubMed 31626055Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
- Background: PubMed 35278203Ficarra S, Thomas E, Bianco A, Gentile A, Thaller P, Grassadonio F, Papakonstantinou S, Schulz T, Olson N, Martin A, Wagner C, Nordstrom A, Hofmann H. Impact of exercise interventions on physical fitness in breast cancer patients and survivors: a systematic review. Breast Cancer. 2022 May;29(3):402-418. doi: 10.1007/s12282-022-01347-z. Epub 2022 Mar 12.
- Background: PubMed 35715631Baker JL, Di Meglio A, Gbenou AS, El Mouhebb M, Iyengar NM, Michiels S, Cottu P, Lerebours F, Coutant C, Lesur A, Tredan O, Vanlemmens L, Jouannaud C, Hrab I, Everhard S, Martin AL, Arveux P, Fabrice A, Vaz-Luis I, Jones LW. Association between physical activity and neoadjuvant chemotherapy completion and pathologic complete response in primary breast cancer: the CANTO study. Br J Cancer. 2022 Sep;127(5):886-891. doi: 10.1038/s41416-022-01870-y. Epub 2022 Jun 17.
- Background: PubMed 38564089Lin D, Sturgeon KM, Muscat JE, Zhou S, Hobkirk AL, O'Brien KM, Sandler DP, Thompson CL. Associations of pre-diagnosis physical activity with treatment tolerance and treatment efficacy in breast cancer patients with neoadjuvant chemotherapy. Breast Cancer. 2024 May;31(3):519-528. doi: 10.1007/s12282-024-01569-3. Epub 2024 Apr 2.
- Background: PubMed 31877085Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26.
- Background: PubMed 28943640Koelwyn GJ, Quail DF, Zhang X, White RM, Jones LW. Exercise-dependent regulation of the tumour microenvironment. Nat Rev Cancer. 2017 Sep 25;17(10):620-632. doi: 10.1038/nrc.2017.78.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREDU Exercise Program and Recommendation Exercise Program in people with Breast Cancer and Lung Cancer (Non-Small Cell), run by University of Vic - Central University of Catalonia at 3 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Meritxell Parareda Ventura, Physiotherapist ((+34) 93 881 60 25, meritxell.parareda@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI) (time frame: Evaluation at the start of chemotherapy (2 weeks after the beginning of the PREDU intervention) and at the end of chemotherapy (18 weeks after the PREDU intervention).). The study lists 2 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 NCT07502963, which also lists 19 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 31 Mar 2026.