This is a national clinical trial (Spain), conducted in approximately 5 sites, where patients who agree to participate will be included in one of two exercise program groups: the experimental group (a combined resistance and aerobic exercise program) and the control group.
The study will begin with a pilot phase involving approximately 74 patients.
Approximately 37 patients in the experimental group will follow a 6-month training program consisting of exercise sessions three alternate days per week (combining resistance and aerobic exercise).
Approximately 37 patients in the control group will receive standard medical care. These patients will be provided with international exercise guidelines for cancer patients.
Patients will continue with their assigned physical activity intervention until the maximum number of months for the intervention, unacceptable toxicity, discontinuation of hormone therapy, or withdrawal of consent-whichever occurs first.
Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups.
Patients ≥18 years of age at signing of ICD.
Documented histologically confirmed HR+/HER2- invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance).
HR testing should utilize an assay consistent with the most recent American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) Guidelines.
Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study.
Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study.
Patients have musculoskeletal injuries.
Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.).
Parallel
Training program
BehavioralTraining program consist on physical activity sessions (combined resistance plus aerobic exercises) that will be performed 3 times per week every-other-day.
Effect of a training program in quality of life questionnaire (QoL)-related to endocrine therapy
To determine the changes from baseline in the QoL-related to endocrine therapy (ET) symptoms measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 45 (EORTC QLQ-BR45) questionnaire (questions 54-56, 63-69). To calculate the scores for each desirable dimension Scoring Manuals will be followed. Summary statistics (mean, mean confidence interval (CI), standard deviation, median and range) of absolute scores and their changes from baseline will be summarized at each assessment time. The comparison between treatment groups will be performed using a linear mixed model. Patients will complete this questionnaire at at baseline and during physical activity intervention: 1.5, 3, 6 and 12 months.
Change from baseline in global QoL
It will be evaluated by the EORTC QLQ-C30 questionnaire (questions 29 and 30). The questionnaire employs twenty-eight 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QoL. For functional and global QoL scales, higher scores represent a better level of functioning and are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represents more severe symptoms. To calculate the scores for each desirable dimension Scoring Manuals will be followed. Summary statistics (mean, mean CI, standard deviation, median and range) of absolute scores and their changes from baseline will be summarized at each assessment time. The comparison between treatment groups will be performed using a linear mixed model. Patients will complete this questionnaire at baseline and during physical activity intervention: 1.5, 3, 6 and 12 months.
Aromatase inhibitor associated musculoskeletal syndrome (AIMSS)
AIMSS will be assessed using the Brief Pain Inventory (BPI) scale. The BPI is a 14-item questionnaire developed for cancer patients to assess the worst pain, pain severity, and pain interference over the past week, reported on a scale of 0 to10. Worst pain is categorized as mild (score from 3 to 4), moderate (score from 5 to 7), or severe pain (score from 8 to 10). Pain severity is measured as the average of responses to questions on worst pain, average pain, least pain, and pain right now. Pain interference is the average of 7 interference items, such as walking, mood, and sleep. The BPI is the most common, valid, and reliable measure to assess joint pain in cancer survivors. Patients will complete this scale at baseline and during physical activity intervention: 1.5, 3, 6 and 12 months.
Fatigue
Fatigue will be measured by the Brief Fatigue Inventory (BFI) scale, which is a one-dimensional questionnaire based on the Brief Pain Inventory (BPI) that assesses the severity and impact of oncologic pain. The BFI is a scale with 11 points (0 to 10), including a dichotomous question about whether the patient felt tired or fatigued in the last 7 days. For each question, 0 is considered "no fatigue" and 10 is "worst fatigue possible," except for the dichotomous question that is not scored. Among the other questions, 3 measures the severity of fatigue in the current, daily situations, and in the last 24 hours. Six questions measure the influence of fatigue in general activities. The total score is the average of all questions. According to the total score, fatigue is classified as mild (from 1 to 3 points), moderate (from 4 to 6 points), and severe (from 7 to 10 points). Patients will complete this scale at baseline and during physical activity intervention: 1.5, 3, 6 and 12 months.
Compliance to treatment
Compliance to treatment will be recorded using the pill counting method and patient diary. Drug compliance is defined as the percentage of doses a study participant has taken (actual consumed dose) compared to the total number of doses prescribed by their physician. The prescribed total dose refers to the comprehensive quantity of medication that is intended to be administered to a patient over a designated treatment period.
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