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Fatigue Reduction Diet (FRD)

Primary Purpose

Chronic Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Cognitive Theory
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fatigue Reduction Diet

General Health Curriculum

Arm Description

The FRD maintains a participant on a diet with their typical caloric intake and replaces some of their calories with the following foods on a daily basis; whole grains, vegetables (one leafy green, one tomato, and on yellow/orange), fruit (one high in vitamin C), fatty fish and nuts and/or seeds. A social cognitive theory intervention method will take place that motivates the participant to change their behavior and lifestyle for overall well being.

Counseling sessions on oral health, healthy eyesight, over-the-counter drug disposal, skin and hair health, cell phone and health, hearing loss, colorectal cancer screening, and preventing colds and flu. A social cognitive theory intervention method will take place that motivates the participant to change their behavior and lifestyle for overall well being.

Outcomes

Primary Outcome Measures

Fatigue in Breast Cancer Survivors
Brief Fatigue Inventory(BFI)will be filled out to assess the changes in fatigue at screening, baseline and the final 3 month visit. The BFI assesses the severity of fatigue and the impact of fatigue on daily functioning in patients with fatigue due to cancer and cancer treatment.

Secondary Outcome Measures

Tolerability, Goals, Beliefs and Expectations of Participants
Tolerability, goals, beliefs and expectations of participants will be obtained through face to face conversations and over the phone. All counseling sessions will be documented into daily logs for future reference.

Full Information

First Posted
July 2, 2013
Last Updated
February 2, 2017
Sponsor
University of Michigan
Collaborators
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01902745
Brief Title
Fatigue Reduction Diet
Acronym
FRD
Official Title
Fatigue Reduction Diet in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fatigue Reduction Diet
Arm Type
Active Comparator
Arm Description
The FRD maintains a participant on a diet with their typical caloric intake and replaces some of their calories with the following foods on a daily basis; whole grains, vegetables (one leafy green, one tomato, and on yellow/orange), fruit (one high in vitamin C), fatty fish and nuts and/or seeds. A social cognitive theory intervention method will take place that motivates the participant to change their behavior and lifestyle for overall well being.
Arm Title
General Health Curriculum
Arm Type
Active Comparator
Arm Description
Counseling sessions on oral health, healthy eyesight, over-the-counter drug disposal, skin and hair health, cell phone and health, hearing loss, colorectal cancer screening, and preventing colds and flu. A social cognitive theory intervention method will take place that motivates the participant to change their behavior and lifestyle for overall well being.
Intervention Type
Behavioral
Intervention Name(s)
Social Cognitive Theory
Intervention Description
Social Cognitive Theory of motivating participants to change their behaviors for overall health and well being.
Primary Outcome Measure Information:
Title
Fatigue in Breast Cancer Survivors
Description
Brief Fatigue Inventory(BFI)will be filled out to assess the changes in fatigue at screening, baseline and the final 3 month visit. The BFI assesses the severity of fatigue and the impact of fatigue on daily functioning in patients with fatigue due to cancer and cancer treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Tolerability, Goals, Beliefs and Expectations of Participants
Description
Tolerability, goals, beliefs and expectations of participants will be obtained through face to face conversations and over the phone. All counseling sessions will be documented into daily logs for future reference.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanna M Zick, Nd, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27913933
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.
Results Reference
derived

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Fatigue Reduction Diet

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