The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity (FEMA)

Feasibility of a Physical Activity Program in Patients With Metastatic Breast Cancer and Overweight: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer; Adiposity; Estrogen-receptor-positive Breast Cancer
• Intervention / Treatment: Behavioral: Physical Activity

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 live long and productive lives, 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 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 metabolic efficacy 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, clinical measures such as blood pressure, weight and bioimpedance, physical performance, questionnaires on quality of life, self-efficacy of cancer coping, sleep quality and feedback on the training program, and one final individual interview.

This intervention study holds significance on multiple fronts. It not only aims to enhance cancer care for our specific patient group but also to: 1) Help us understand the clinical and translational metabolic factors associated with excess weight and their impact on mental health and quality of life; 2) improve cancer care for all metastatic breast cancer patients, regardless of their weight status; and 3) potentially improve cancer care for all breast cancer patients receiving endocrine-based treatments.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Signe SB Borgquist, MD, PhD; Phone Number: +45 22 62 45 25; Email: signe.borgquist@auh.rm.dk
• Study Contact Backup: Name: May W Nielsen, Bsc.Med.; Phone Number: +45 29 90 66 05; Email: maywni@rm.dk

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus N, Central Denmark Region, Denmark, 8200
      • Recruiting
      • Department of Oncology, Aarhus University Hospital
      • Contact: Signe Borgquist, MD, PhD; Phone Number: + 45 22 62 45 25; Email: signe.borgquist@auh.rm.dk
      • Contact: May W Nielsen, Bsc.Med.; Phone Number: +45 29 90 66 05; Email: maywni@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 14 participants	Behavioral: Physical Activity; 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.
No Intervention: Observational Arm; 7 participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence as assessed by attendance rate	Assess adherence measured by attendance-% to the physical activity program of at least 80%.	1 year
Metabolic efficacy assessed by change in metabolic score	Change in metabolic score calculated as the sum of Z-transformed levels of mid-blood pressure [(systolic blood pressure + diastolic blood pressure)/2], glucose, and triglycerides from baseline to end of intervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived satisfaction assessed by qualitative interviews	Assess the participants' satisfaction and personal experiences in the program through personal interviews, following a self-developed interview guide.	1 year
Health-related quality of life as assessed by EORTC-QLQ-30	Change in health-related quality of life measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	1 year
Cancer coping as assessed by CBI-12	Change in cancer coping measured with Cancer Behavior Inventory-12 (CBI-12)	1 year
Sleep quality as assessed by PSQI	Change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI)	1 year
Insomnia as assessed by ISI	Change in insomnia assessed by Insomnia Severity Index (ISI)	1 year
Change in C-reactive protein	Change in circulation levels of C-reactive protein measured in mg/L	1 year
Change in leukocytes	Change in circulation levels of total leukocytes measured in 10^9/L	1 year
Change in HbA1c	Change in HbA1c measured in mmol/mol	1 year
Change in LDL cholesterol	Change in LDL cholesterol measured in mmol/L	1 year
Change in HDL cholesterol	Change in HDL cholesterol measured in mmol/L	1 year
Change in BMI	Change in BMI kg/m^2	1 year
Fat mass	Change in fat mass in kilogram	1 year
Muscle mass	Change in muscle mass in kilogram	1 year
Visceral fat	Change in visceral fat in kilogram	1 year
VO2 max	Change in VO2 max measured by Watt-Max test	1 year
Handgrip strength	Change in handgrip strength in kilogram measured by dynamometer after 12 weeks	1 year
Sit-rising	Change in number of performed sit-rising in 30 seconds measured through a sitting-rising test	1 year

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Signe SB Borgquist, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Obesity; Metastatic Breast Cancer; Endocrine Therapy; Adiposity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Breast Neoplasms; Obesity
• Other Study ID Numbers: 1-10-72-165-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No