Muscle Loss and Fatigue as a Consequence of Radiotherapy

Breast Cancer Clinical Trial

— MUSFAT  

Official title:

Muscle Loss and Fatigue as a Consequence of Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02567669
• Other study ID #: 008778
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Essentia Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue
• Sarcopenia

Intervention

Radiation:
• standard postoperative radiotherapy for breast cancer
subjects will undergo ct scans to assess muscle mass and questionnaires to assess fatigue at 4 defined time points during and after radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Essentia Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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