Chronic FatigueFRDNCT01902745
Fatigue Reduction Diet
A study testing Social Cognitive Theory in people with Chronic Fatigue, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue
- What is being tested?
- Social Cognitive Theory
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue Reduction Diet in Breast Cancer Survivors
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.
- Conditions
- Chronic Fatigue
- Being tested
- Social Cognitive Theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognitive TheoryBehavioural
Social Cognitive Theory of motivating participants to change their behaviors for overall health and well being.
| Study group | Role | What they receive |
|---|---|---|
| Fatigue Reduction Diet | Active comparator | 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. Receives: Behavioral: Social Cognitive Theory |
| General Health Curriculum | Active comparator | 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. Receives: Behavioral: Social Cognitive Theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic FatigueStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan Rogel Cancer Center
- Responsible party
- Principal investigator, Suzanna Zick, University of Michigan
- Investigators
- Suzanna M Zick, Nd, MPH, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902745
- Sponsor's protocol ID
- HUM00075741
- Acronym
- FRD
- Status last verified
- Feb 2017
- First submitted
- 2 Jul 2013
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27913933
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Reduction Diet in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01902745
- Acronym / sponsor ID
- FRD / HUM00075741
- Conditions
- Chronic Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Michigan Rogel Cancer Center
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jul 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fatigue Reduction Diet | Active comparator | Behavioral: Social Cognitive TheoryThe 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. |
| General Health Curriculum | Active comparator | Behavioral: Social Cognitive TheoryCounseling 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)]
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Social Cognitive TheorySocial Cognitive Theory of motivating participants to change their behaviors for overall health and well being. | Behavioural | Fatigue Reduction Diet, General Health Curriculum |
Primary outcome
Fatigue in Breast Cancer Survivors
Time frame: 12 weeks
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.
1 secondary outcome
Tolerability, Goals, Beliefs and Expectations of Participants
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Derived from this study: PubMed 27913933Zick 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.
Related trials for Chronic Fatigue
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Active, not recruiting
The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients
Chronic Insomnia, Cancer-related Problem/Condition
Not yet recruiting
Manual Acupuncture for Intradialytic Fatigue in CKD Patients
Intradialytic Fatigue, Chronic Kidney Disease
RecruitingPhase 3
Wisconsin Ginseng for Decreasing Cancer Related Fatigue
Malignant Solid Neoplasm, Chronic Lymphocytic Leukemia
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.
Suzanna M Zick, Nd, MPH principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognitive Theory in people with Chronic Fatigue, run by University of Michigan at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fatigue in Breast Cancer Survivors (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902745, which also lists 1 linked publication.
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 6 Feb 2017.