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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

NCT07502963 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

Interventions

OTHER

PREDU Exercise Program

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.

OTHER

Recommendation Exercise Program

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.

Sponsors & Collaborators

  • Col·legi Fisioterapeutes de Catalunya

    collaborator UNKNOWN

  • University of Vic - Central University of Catalonia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-10-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502963 on ClinicalTrials.gov