Muscle Loss and Fatigue as a Consequence of Radiotherapy

NCT02567669 | Active Not Recruiting

• 1 other identifier: 008778
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Fatigue; Sarcopenia

Keywords

radiotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Changes in cross-sectional muscle area within the radiation treatment area measured on ct scans

  5 months

Interventions

standard postoperative radiotherapy for breast cancer RADIATION

subjects will undergo ct scans to assess muscle mass and questionnaires to assess fatigue at 4 defined time points during and after radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with nonmetastatic breast cancer with indications for postoperative radiotherapy

You may qualify if:

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

You may not qualify if:

• Pregnant
• Inability to meet eligibility requirements -

Sponsors & Collaborators

• Essentia Health: lead

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Sarcopenia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Ken Dornfeld, MD PhD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 5, 2015
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share