Effect of High-Dose Guarana And Cancer-Related Fatigue

  • STATUS
    Recruiting
  • End date
    Apr 21, 2023
  • participants needed
    60
  • sponsor
    University of Rochester
Updated on 4 June 2022

Summary

This research will examine the effectiveness of a guaraná nutrition energy bar supplement on cancer-related fatigue based on scores from fatigue questionnaires. Participants will be randomized to one of three study arms: 1) two guaraná energy bars/day, 2) one guaraná energy bar/day 3) usual-care only/ no guaraná energy bars during study in cancer patients who have completed cancer treatment. We would also like to find out if this energy bar supplement improves physical performance, mood and reduces plasma glutamine and inflammation.

Details
Condition Cancer-related Fatigue
Treatment Usual Care, Guarana herb
Clinical Study IdentifierNCT03897556
SponsorUniversity of Rochester
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a confirmed diagnosis of a malignant solid tumor between 4 and 36 months post-treatment (pathology report or MD documentation)
Completed all forms of standard treatment (surgery, chemotherapy, radiation therapy, and/or immunotherapy) between 4 and 36 months prior to enrollment in the study
Be 18 years of age or older
Have cancer-related fatigue, as indicated by a response of a 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0": = 'no fatigue' and "10" = 'as bad as you can imagine' as taken from a single item question on the Symptom Inventory Questionnaire
Be able to read English (since the assessment materials are in printed format)

Exclusion Criteria

Participants must not: Have used guaraná supplements within the previous two months
Self-report that they are very sensitive to caffeine
Uncontrolled hypertension
Have an allergy to walnuts, seaweed, soybeans and/or chocolate
Use medications for which caffeine intake is contraindicated including: β-adrenergic agonists, and/or medications that contain pseudoephedrine
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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