Clinical trial · Interventional
The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity
Feasibility of a Physical Activity Program in Patients With Metastatic Breast Cancer and Overweight: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adiposity | — | UNRESOLVED | — |
| Estrogen-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- 14 participants
- interventionNames
- Behavioral: Physical Activity
- type
- NO_INTERVENTION
- label
- Observational Arm
- description
- 7 participants
Primary outcomes (5)
- measure
- Recruitment rate
- timeFrame
- 1 year
- description
- Recruitment rate calculated by the amount of included partcipants of those eligible
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed metastatic breast cancer * BMI ≥ 25 * Receive first-line endocrine-based therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDWissing M, Skovlund P, Drysdale S, Amidi A, Zachariae R, Laurberg T, Borgquist S. Feasibility of an exercise program in endocrine-treated metastatic breast cancer patients with overweight: protocol for the FEMA study. Pilot Feasibility Stud. 2025 Apr 2;11(1):36. doi: 10.1186/s40814-025-01621-9. PMID 40176194