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NCT01902745 · ClinicalTrials.gov registry record · NA

Fatigue Reduction Diet

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
30
Enrollment target

NCT01902745: Completed NA study, sponsored by University of Michigan.

NCT01902745 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01902745, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target

Study 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

Primary Outcome

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.

Interventions

  • BEHAVIORAL Social Cognitive Theory

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2013-11
Est. Completion 2015-09
Phase NA
University of Michigan

1,327 total trials

What the finished NCT01902745 record still lists

NCT01902745 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Social Cognitive Theory is the first listed.

NCT01902745 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01902745 about?

NCT01902745 is a clinical study titled "Fatigue Reduction Diet". 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 qualit...

What is the current status of trial NCT01902745?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2013-11. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01902745?

The interventions under investigation include: Social Cognitive Theory (BEHAVIORAL).

Who is sponsoring clinical trial NCT01902745?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01902745's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01902745, the US trial registry maintained by the National Library of Medicine. NCT01902745 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.