protocolSection identificationModule nctId: NCT06343987, orgStudyIdInfo id: 1-10-72-165-23, briefTitle: The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Aarhus University Hospital, class: OTHER, collaborators name: Danish Cancer Society, descriptionModule briefSummary: 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 and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care.Participants will randomized 2:1 to either a physical activity program or care as usual., conditionsModule conditions: Metastatic Breast Cancer, conditions: Estrogen-receptor-positive Breast Cancer, conditions: Adiposity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Continuous inclusion. Randomized 2:1 - intervention group and observational group, respectively., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Physical Activity, outcomesModule primaryOutcomes measure: Adherence as assessed by attendance rate, primaryOutcomes measure: Metabolic efficacy assessed by change in metabolic score, secondaryOutcomes measure: Perceived satisfaction assessed by qualitative interviews, secondaryOutcomes measure: Health-related quality of life as assessed by EORTC-QLQ-30, secondaryOutcomes measure: Cancer coping as assessed by CBI-12, secondaryOutcomes measure: Sleep quality as assessed by PSQI, secondaryOutcomes measure: Insomnia as assessed by ISI, secondaryOutcomes measure: Change in C-reactive protein, secondaryOutcomes measure: Change in leukocytes, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in LDL cholesterol, secondaryOutcomes measure: Change in HDL cholesterol, secondaryOutcomes measure: Change in BMI, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Visceral fat, secondaryOutcomes measure: VO2 max, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Sit-rising, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oncology, Aarhus University Hospital, status: RECRUITING, city: Aarhus N, state: Central Denmark Region, zip: 8200, country: Denmark, contacts name: Signe Borgquist, MD, PhD, role: CONTACT, phone: + 45 22 62 45 25, email: signe.borgquist@auh.rm.dk, contacts name: May W Nielsen, Bsc.Med., role: CONTACT, phone: +45 29 90 66 05, email: maywni@gmail.com, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False