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 | Not Yet Recruiting

• 1 other identifier: PREDU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.

• Change in Cardiorespiratory Capacity

  Measurements are performed at baseline, at 2 weeks, at 18 weeks, and at 24 weeks after completion of the intervention.

Study Arms (2)

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.

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.

Other: PREDU Exercise Program

Interventions

PREDU Exercise Program OTHER

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.

Experimental group

Recommendation Exercise Program OTHER

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.

Control group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Col·legi Fisioterapeutes de Catalunya: collaborator

Study Sites (3)

Consorci Hospitalari de Vic

Vic, Barcelona, 08500, Spain

Location

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, Spain

Location

Hospital Universitari de la Santa Creu

Vic, Barcelona, 08500, Spain

Location

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MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Central Study Contacts

Meritxell Parareda Ventura, Physiotherapist

CONTACT

(+34) 93 881 60 25; meritxell.parareda@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Professor Meritxell Parareda Ventura

Model Details: A randomized clinical trial with blinded outcomes assessor, longitudinal and prospective design is proposed, in accordance with the CONSORT 2025 guidelines.

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

ES (3)