Muscle Loss and Fatigue as a Consequence of Radiotherapy

NCT ID: NCT02567669

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Fatigue Sarcopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Essentia Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ken Dornfeld, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Essentia Health

Other Identifiers

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008778

Identifier Type: -

Identifier Source: org_study_id

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