Clinical trial NCT01902745: Fatigue Reduction Diet
Official title: Fatigue Reduction Diet in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Michigan Rogel Cancer Center
First posted: 2013-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 breast cancer (BC) survivors. PCRF is associated with decreased quality of life, decreased sleep quality, depression, chronic pain and impaired cognition. Currently, there are few treatment options for PCRF and existing treatment options are associated with significant costs, are a considerable burden on the part of the patient, or have unacceptable side-effects. As such, there is a clear need to conduct studies evaluating the impact of safe, easy to implement and inexpensive treatments for PCRF in BC survivors.

Individualized nutritional counseling has been found to be beneficial for decreasing fatigue and improving quality of life in cancer patients receiving treatment.However, there is a dearth of research examining the use of diet for treating fatigue in cancer survivors. Our preliminary data in 40 adult cancer survivors found that fatigue severity was associated with decreased intake of key food groups, e.g., green leafy vegetables, and nutrients, e.g., omega-3 fatty acids, as reported in diet records. However, diet records are often not highly correlated with actual nutrient concentrations in the body and tend to capture short-term dietary habits not long-term patterns. The main objective of this research is to expand upon and confirm our cross-sectional preliminary data and to take advantage of a pilot clinical dietary study we are conducting by examining key nutrient differences in biological samples in the breast cancer survivors. By examining differences in biological samples we will be able to explore three key questions, which will directly influence our future interventional studies: (1) to determine if there are actual differences in concentrations of key nutrients in body tissue and which nutrients these are; (2) to assess if a dietary intervention focused on improving fatigue in BC survivors changes baseline levels of key nutrients; and (3) what is the effect size and variability of change in key nutrients in body tissue both at baseline and after a dietary intervention.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Fatigue in Breast Cancer Survivors
timeFrame: 12 weeks
Secondary outcomes:
measure: Tolerability, Goals, Beliefs and Expectations of Participants
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suzanna M Zick, Nd, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zick SM, Colacino J, Cornellier M, Khabir T, Surnow K, Djuric Z. Fatigue reduction diet in breast cancer survivors: a pilot randomized clinical trial. Breast Cancer Res Treat. 2017 Jan;161(2):299-310. doi: 10.1007/s10549-016-4070-y. Epub 2016 Dec 2.