Muscle Loss and Fatigue as a Consequence of Radiotherapy (MUSFAT)

This study examines the extent of systemic muscle loss and the degree of fatigue experienced by breast cancer patients undergoing radiotherapy. This study seeks to identify whether muscle loss occurs outside the radiation fields and if muscle loss is correlated with the degree of fatigue.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Fatigue; Sarcopenia
• Intervention / Treatment: Radiation: standard postoperative radiotherapy for breast cancer

Detailed Description

This study uses a patient reported survey to assess fatigue prior to radiotherapy for breast cancer. Fatigue is measured again at the completion of radiation treatments and at one and three months following completion of radiation.

Muscle measurements are made outside the treatment area using ct scans prior to radiation treatment, at the completion of radiation treatment and at one and three months after radiation treatment. The degree of fatigue and changes in muscle will be assessed. Changes will be correlated to determine if muscle loss contributes to fatigue.

• Study Type: Observational
• Enrollment (Estimated): 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with nonmetastatic breast cancer with indications for postoperative radiotherapy

Description

Inclusion Criteria:

1. Women Age ≥ 18 years
2. Non-metastatic breast cancer for which post-operative radiation treatment has been recommended as standard of care
3. Able to provide informed consent
4. Able to complete the Brief Fatigue Inventory questionnaire -

Exclusion Criteria:

1. Pregnant
2. Inability to meet eligibility requirements -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"	Subjects will complete the Brief Fatigue Inventory questionnaire on the first day of radiation treatment, the last day of radiation treatment and one month and three months after the last radiation treatment. All dates are +/- one week. The length of radiation treatment will be determined by the treating physician as standard of care, typically four to six weeks depending on disease characteristics.	5 months
Changes in muscle area outside the radiation treatment area determined on cross sectional anatomy from CT scan images	Subjects will undergo ct scan imaging on the first day of radiation treatment, the last day of radiation treatment and one month and three months after the last radiation treatment. All dates are +/- one week. The length of radiation treatment will be determined by the treating physician as standard of care, typically four to six weeks depending on disease and patient characteristics. Muscle area will be determined on specified anatomic levels using automated image analysis of CT images.	5 months
Correlation between muscle area and fatigue	Changes in cross-sectional muscle area during and after radiotherapy will be compared with changes in self reported fatigue to determine if correlations exist between changes in fatigue and cross sectional muscle area.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cross-sectional muscle area within the radiation treatment area measured on ct scans	cross sectional muscle area within the radiation treatment area will be measured on ct scan images at anatomic levels corresponding to irradiated tissue. changes in muscle area over the course of treatment and following treatment will be determined. muscle area will be measured on the first day of radiation treatment, the last day of radiation treatment and at one month and three months after the last radiation treatment with ct scans at all four timepoints.	5 months

Collaborators and Investigators

• Sponsor: Essentia Health
• Investigators: Principal Investigator: Ken Dornfeld, MD PhD, Essentia Health

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimated): October 5, 2015

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: radiotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Fatigue; Sarcopenia
• Other Study ID Numbers: 008778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: meeting presentation and publication