Clinical trial NCT06343987: The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity
Official title: Feasibility of a Physical Activity Program in Patients With Metastatic Breast Cancer and Overweight: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Estrogen-receptor-positive Breast Cancer
Adiposity
Keywords: Metastatic Breast Cancer
Physical Activity
Adiposity
Endocrine Therapy
Obesity
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2024-04-03
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Continuous inclusion. Randomized 2:1 - intervention group and observational group, respectively.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 year
measure: Adherence to the training program
timeFrame: 1 year
measure: Retention
timeFrame: 1,5 years
measure: Adherence to other study procedures
timeFrame: 1,5 years
measure: Acceptability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Health-related quality of life as assessed by EORTC-QLQ-30
timeFrame: Until the end of study
measure: Metabolic score
timeFrame: Until the end of study
measure: Self-efficacy of cancer coping as assessed by CBI-12
timeFrame: Until end of study
measure: Sleep quality as assessed by PSQI
timeFrame: Until end of study
measure: Insomnia as assessed by ISI
timeFrame: Until end of study
measure: Change in C-reactive protein
timeFrame: 1 year
measure: Change in leukocytes
timeFrame: 1 year
measure: Change in HbA1c
timeFrame: 1 year
measure: Change in LDL cholesterol
timeFrame: 1 year
measure: Change in HDL cholesterol
timeFrame: 1 year
measure: Change in BMI
timeFrame: 1 year
measure: Fat mass
timeFrame: 1 year
measure: Muscle mass
timeFrame: 1 year
measure: Visceral fat
timeFrame: 1 year
measure: VO2 max
timeFrame: 1 year
measure: Handgrip strength
timeFrame: 1 year
measure: Sit-rising
timeFrame: 1 year
Locations:
city: Aarhus N
country: Denmark
facility: Department of Oncology, Aarhus University Hospital
state: Central Denmark Region
Study officials:
affiliation: Aarhus University Hospital
name: Signe SB Borgquist, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: