Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Patients With Breast Cancer: Protocol for a Randomized Clinical Trial

Background: Breast cancer is the second most common cancer in women worldwide. Treatments for this disease often result in side effects such as pain, fatigue, loss of muscle mass, and reduced quality of life. Physical exercise has been shown to effectively mitigate these side effects and improve the quality of life in patients with breast cancer. Objective: This randomized clinical trial aims to evaluate the efficacy of a 12-week supervised exercise program on pain, physical function, and quality of life in female patients with cancer. Methods: This randomized, double-blind clinical trial will recruit 325 participants, divided into an intervention group receiving the exercise program and a control group receiving standard care recommendations. Outcome measures, including pain (assessed via the Brief Pain Inventory), physical function (Disability of the Arm, Shoulder, and Hand Questionnaire), and quality of life (European Organization for Research andTreatment of Cancer QLQ-C30 and European Organization for Research andTreatment of Cancer QLQ-BR23), will be evaluated at baseline, immediately post intervention, and 12 weeks post intervention. Statistical analysis will involve repeated measures of ANOVA and MANOVA to determine the significance of the intervention's effects across time points. Results: Recruitment and data collection will commence in February of 2025, and data analysis is scheduled for completion at the end of 2025. No results are currently available Conclusions:Physical exercise is anticipated to play a significant role in alleviating pain, enhancing physical function, and improving the quality of life in female patients with cancer. This study will provide robust evidence to support the integration of supervised exercise into standard care protocols for this population. Trial Registration: ClinicalTrials.gov NCT06618690; https://clinicaltrials.gov/ct2/show/NCT06618690 International Registered Report Identifier (IRRID): PRR1-10.2196/63891