The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity
- Conditions
- Metastatic Breast CancerAdiposityEstrogen-receptor-positive Breast Cancer
- Interventions
- Behavioral: Physical Activity
- Registration Number
- NCT06343987
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.
The aim of the study is to assess the feasibility of a 12-week physical activity program in this patient group in terms of adherence, recruitment rate, retention and acceptability. Potential effects on metabolic health, body composition, physical performance, obesity-related biomarkers and patient-related outcomes are explored. The hypothesis is that improving metabolic health and health-related quality of life through physical activity can optimize cancer care.
Participants will randomized 2:1 to either a physical activity program or care as usual.
- Detailed Description
Women with overweight and obesity not only have a greater risk of developing breast cancer; they also have a worse prognosis. At diagnosis, women with overweight are more likely to have more advanced breast cancer and face an elevated risk of developing distant metastases compared to breast cancer patients with normal weight. Despite advanced disease, many patients with metastatic breast cancer can live for several years, but experience weight-gain, physical de-conditioning, and decreasing quality of life. On top of this, patients with endocrine-responsive metastatic breast cancer often receive treatment with aromatase inhibitors which can induce metabolic changes, increasing the risk of weight-gain and type 2 diabetes. The hypothesis is that improving metabolic health and quality of life through physical activity in patients with metastatic breast cancer and overweight receiving endocrine-based treatment can optimize cancer care.
Therefore, in this randomized controlled trial, the investigators will launch a 12-week physical intervention program including 21 participants to investigate the feasibility and potential effects hereof. The program will take place at Steno Diabetes Centre Aarhus, and patients are included from the Department of Oncology, Aarhus University Hospital. The physical activity program consists of training 3 times a week with a supervising physiotherapist. Throughout the study, data will be collected through blood samples, blood pressure measurements, bioelectrical impedance analysis, physical performance tests, questionnaires on quality of life, self-efficacy of cancer coping, sleep quality and a self-developed evaluation questionnaire, and one individual semi-structured interview.
This feasibility study will guide the decision of a future, full-scale study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 21
- Diagnosed metastatic breast cancer
- BMI ≥ 25
- Receive first-line endocrine-based therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.
- Physical health condition that either is unsafe for participation or prevents the patient from participating adequately in the physical activity program.
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Physical Activity 14 participants
- Primary Outcome Measures
Name Time Method Recruitment rate 1 year Recruitment rate calculated by the amount of included partcipants of those eligible
Adherence to the training program 1 year Adherence to the training program assessed by the mean attendance rate
Retention 1,5 years Retention rate to the study assessed by the proportion of participants in each study arm that completes the study period
Adherence to other study procedures 1,5 years Adherence to other study procedures assessed by the proportion of completed questionnaires and blood samples at the specified time-points
Acceptability 1 year Acceptability of the study intervention assessed by the proportion of participants in the intervention arm that anwers "yes" to the question: "Would you recommend others to participate in the physical activity program?"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Oncology, Aarhus University Hospital
🇩🇰Aarhus N, Central Denmark Region, Denmark