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.

Plain English Summary

Effectiveness of a Multimodal Outpatient Supervised Physical Activity Program to Improve Tolerance and Efficacy of Chemotherapy in Adults With Breast, Lung and Colon Cancer is a Not Applicable clinical trial sponsored by University of Vic - Central University of Catalonia studying Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer, Physical Activity, Neoadjuvant Chemotherapy Tolerance, Strength and Endurance. This study tests if a supervised exercise program before and during chemotherapy helps patients with breast, lung, or colon cancer tolerate treatment better and respond more effectively. It is for adults aged 35-65 diagnosed with stage II, III, or IV breast, lung, or colon cancer who are scheduled to start chemotherapy. Participants will engage in supervised exercise sessions and may also follow unsupervised exercise recommendations. The alternative is standard chemotherapy without a structured exercise program. The trial aims to enroll 70 participants.

Official 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

Here is what you need to know about eligibility for this trial. You can join if you are a man or woman aged 35 to 65 with stage II, III, or IV breast, lung, or colon cancer, and are about to start chemotherapy. You cannot join if you have physical or nerve problems that stop you from exercising, active infections, certain serious health conditions like severe lung or heart problems, a BMI over 35, or are pregnant. You must be able and willing to give written consent to participate. This trial is studying Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer, Physical Activity, Neoadjuvant Chemotherapy Tolerance, Strength and Endurance, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures will show if the exercise program helps patients receive their full chemotherapy dose (tolerance) and if their tumors shrink more effectively (efficacy). The specific primary outcome measures are: Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI) (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 (CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a gap in cancer care by investigating if a structured exercise program can help patients better withstand and benefit from chemotherapy, potentially leading to improved treatment This research targets Breast Cancer, Lung Cancer (Non-Small Cell), Colorectal Cancer, Physical Activity, Neoadjuvant Chemotherapy Tolerance, Strength and Endurance, where improved treatment options are needed.

Investor Insight

This trial signals a growing interest in supportive care interventions for cancer patients, potentially improving treatment adherence and outcomes, which could be valuable for pharmaceutical and healt

Is This Trial Right for Me?

Ask your doctor if this exercise program is right for you and how it might interact with your chemotherapy. Participation involves attending supervised exercise sessions before and during chemotherapy, and potentially doing exercises on your own. Be prepared for regular exercise sessions that will be tailored to your ability and cancer treatment. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 70 participants

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 con
• 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 pop

Primary Outcomes

• Chemotherapy Treatment Tolerance assessed by Relative Dose Intensity (RDI) (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 (CR is evaluated at baseline (diagnosis) and at the end of chemotherapy (18 weeks after the PREDU intervention).)

Secondary Outcomes

• 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.)

Full Eligibility Criteria

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 Locations

• Consorci Hospitalari de Vic, Vic, Barcelona, Spain
• 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, Spain
• Hospital Universitari de la Santa Creu, Vic, Barcelona, Spain

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Lung Cancer (Non-Small Cell)
• Colorectal Cancer
• Cancer Treatment
• Chemotherapy
• Neoadjuvant Therapy
• Physical Activity
• Exercise Oncology
• Supportive Care
• Oncology

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