Status:
COMPLETED
Fatigue Reduction Diet
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
University of Michigan Rogel Cancer Center
Conditions:
Chronic Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There are over 2 million breast cancer survivors today. Persistent cancer-related fatigue (PCRF), a state of being tired or weary, is one of the most common and distressing symptoms experienced by bre...
Eligibility Criteria
Inclusion
- 18 years of age and older
- Diagnosis of breast cancer
- Have completed all cancer related treatments (i.e. surgery, chemotherapy, radiotherapy, immunotherapy, etc.) at least 1 year prior to enrollment except hormone therapy which must have been initiated at least three weeks prior to enrollment
- Apparently cancer-free
- Have a complaint of persistent, moderate to severe fatigue despite standard treatment \[defined as ≥ 4 on the Brief Fatigue Inventory (BFI)\]
- Dietary eligibility requirements from a seven-day food record fruit and vegetable (FV) intake less than \<5.5 servings/day, not including potatoes and iceberg lettuce.
Exclusion
- Participants with BMI \<18.5 or \>35 kg/m2 will be excluded since low BMI could indicate eating disorders and high BMI values, above the midpoint of the obesity range, could indicate more prevalent health problems
- Have a diagnosis of untreated hypo- or hyper- thyroidism
- Pregnant, wanting to become pregnant or lactating women
- Unable to read and/ or write in English
- Planning on starting or stopping any chronic supplements or medications within six weeks prior to or throughout the study period
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01902745
Start Date
November 1 2013
End Date
September 1 2015
Last Update
February 6 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48106