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.
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
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
Parallel
PREDU Exercise Program
Other interventionThe 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.
Recommendation Exercise Program
Other interventionParticipants 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.
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.
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.
Cancer-Related Fatigue Score assessed by Piper Fatigue Scale
Fatigue is measured using the Piper Fatigue Scale, a self-reported instrument with 22 items scored from 0 to 10, where higher scores indicate greater fatigue. The scale evaluates four dimensions of subjective fatigue: severity, sensory impact, cognitive impact, and mood. The total fatigue score is calculated by summing the scores of the four dimensions and dividing by four. Measured on a numerical scale from 0 to 10. Compare the results of the four assessments and between the groups.
Static muscle strenght (kg) assessed by Handheld Dynamometer
Peak muscle strength, expressed in kilograms (kg), assessed using a handheld dynamometer. Comparisons are made across all four assessments and between the groups.
Dynamic Muscle Strength (kg) using Brzycki Equation
Estimated dynamic muscle strength, expressed in kilograms (kg), calculated from n-repetition maximum (n-RM) using the Brzycki equation.
Change in Quality of Life Score
Quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Scores are on a 0-100 scale, with higher scores indicating better functioning or quality of life, whereas for symptom scales, higher scores indicate greater symptom burden. Compare the results of the four assessments and between the groups.
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University of Vic - Central University of Catalonia
Lead sponsor
Col·legi Fisioterapeutes de Catalunya
Collaborator
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