Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer (PREDU)

University of Vic - Central University of Catalonia

Status: Not yet enrolling

Conditions: Lung Cancer (Non-Small Cell); Breast Cancer; Neoadjuvant Chemotherapy Tolerance; Physical Activity; Strength and Endurance; Colorectal Cancer

Treatments: Other: PREDU Exercise Program; Other: Recommendation Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07502963

PREDU

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Recommendation Exercise Program

Experimental group

Experimental group

Description:

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.

Treatment:

Other: PREDU Exercise Program