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Trial Title:
The FEMA Study: Feasibility of Exercise in Patients with Metastatic Breast Cancer and Adiposity
NCT ID:
NCT06343987
Condition:
Metastatic Breast Cancer
Estrogen-receptor-positive Breast Cancer
Adiposity
Conditions: Official terms:
Breast Neoplasms
Obesity
Conditions: Keywords:
Metastatic Breast Cancer
Physical Activity
Adiposity
Endocrine Therapy
Obesity
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Continuous inclusion. Randomized 2:1 - intervention group and observational group,
respectively.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Physical Activity
Description:
12-week physical activity program with training 3 times a week. The training consists of
high-intensity training such as weight-lifting and cardiovascular training, and
low-intensity training such as relaxation and stretching.
Arm group label:
Intervention Arm
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Oncology, Aarhus University Hospital
Address:
City:
Aarhus N
Zip:
8200
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Signe Borgquist, MD, PhD
Phone:
+ 45 22 62 45 25
Email:
signe.borgquist@auh.rm.dk
Contact backup:
Last name:
May W Nielsen, Bsc.Med.
Phone:
+45 29 90 66 05
Email:
maywni@gmail.com
Start date:
February 19, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Danish Cancer Society
Agency class:
Other
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06343987
