Muscle Loss and Fatigue as a Consequence of Radiotherapy

Active, not recruiting

• Conditions: Breast Cancer; Sarcopenia; Fatigue

• Registration Number: NCT02567669
• Lead Sponsor: Essentia Health

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Study Start: 2016-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"	5 months	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.
Changes in muscle area outside the radiation treatment area determined on cross sectional anatomy from CT scan images	5 months	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.
Correlation between muscle area and fatigue	5 months	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.

Secondary Outcome Measures

Name	Time	Method
Changes in cross-sectional muscle area within the radiation treatment area measured on ct scans	5 months	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.