Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Toleranc… (NCT07502963) | Clinical Trial Compass
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Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer
Spain70 participantsStarted 2026-04
Plain-language 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.
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.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI)
Timeframe: 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).
2
Complete Response (CR) Rate according to RECIST 1.1 Criteria
Timeframe: CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).
Trial details
NCT IDNCT07502963
SponsorUniversity of Vic - Central University of Catalonia