Breast CancerMUSFATNCT02567669
Muscle Loss and Fatigue as a Consequence of Radiotherapy
An observational study of Breast Cancer and Fatigue, run by Essentia Health.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue, Sarcopenia
- What is being tested?
- standard postoperative radiotherapy for breast cancer
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with nonmetastatic breast cancer with indications for postoperative radiotherapy
Who may be able to join
- 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 -
Who cannot join
- Pregnant
- Inability to meet eligibility requirements -
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Fatigue, Sarcopenia
- Being tested
- standard postoperative radiotherapy for breast cancer
- Keywords
- radiotherapy
- Medical subject headings
- Breast Neoplasms, Fatigue, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard postoperative radiotherapy for breast cancerRadiation
subjects will undergo ct scans to assess muscle mass and questionnaires to assess fatigue at 4 defined time points during and after radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essentia Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ken Dornfeld, MD PhD, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567669
- Sponsor's protocol ID
- 008778
- Acronym
- MUSFAT
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2015
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: meeting presentation and publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Loss and Fatigue as a Consequence of Radiotherapy
- ClinicalTrials.gov ID
- NCT02567669
- Acronym / sponsor ID
- MUSFAT / 008778
- Conditions
- Breast Cancer, Fatigue, Sarcopenia
- Keywords
- radiotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Essentia HealthUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with nonmetastatic breast cancer with indications for postoperative radiotherapy
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (2 listed)
- Pregnant
- Inability to meet eligibility requirements -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard postoperative radiotherapy for breast cancersubjects will undergo ct scans to assess muscle mass and questionnaires to assess fatigue at 4 defined time points during and after radiotherapy | Radiation | – |
Primary outcome
Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Changes in cross-sectional muscle area within the radiation treatment area measured on ct scans
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. meeting presentation and publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Dornfeld, MD PhD principal investigator
Essentia Health
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Fatigue, run by Essentia Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory" (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.