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Effect of High-Dose Guarana And Cancer-Related Fatigue

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ClinicalTrials.gov Identifier: NCT03897556
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Julia Inglis, University of Rochester

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer-related Fatigue Dietary Supplement: Guarana herb Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a three-arm study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors
Estimated Study Start Date : October 20, 2019
Estimated Primary Completion Date : April 20, 2021
Estimated Study Completion Date : May 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High-dose
This arm consists of cancer survivors who receive two guarana energy bars to take per day for six weeks; one in the morning and one around lunch time.
Dietary Supplement: Guarana herb
The intervention is a functional food bar produced in a licensed commercial kitchen that contains guarana powder as well as dates, raisins, oats, spirulina, walnuts, flour, coconut butter, soybean oil, xanthan gum and chocolate chips.

Active Comparator: Low-Dose
This arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only.
Dietary Supplement: Guarana herb
The intervention is a functional food bar produced in a licensed commercial kitchen that contains guarana powder as well as dates, raisins, oats, spirulina, walnuts, flour, coconut butter, soybean oil, xanthan gum and chocolate chips.

Usual Care
This arm receives usual-care only as cancer survivors.
Other: Usual Care
Participant will receive 'usual-care' for cancer survivors. At the end of the study, after completing the Final Visit, they will receive 21 guarana energy bars to thank them for being in the study.




Primary Outcome Measures :
  1. The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey [ Time Frame: Baseline to final visit (six weeks) ]
    Participant will complete the Brief Fatigue Inventory Survey at baseline, midpoint and the final assessments. The scale is an 11-point scale, with a higher value indicating worse or greater level of fatigue.


Secondary Outcome Measures :
  1. The adherence to taking guarana energy bars: participant ate ≥ 80% of the guaraná energy bars assigned to them over the course of the study. [ Time Frame: Baseline to final visit (six weeks) ]
    Participants will bring in any leftover bars they don't consume during the study at midpoint and final assessments.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897556


Contacts
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Contact: Julia E Inglis, PhD, RD 352-375-4223 Julia_Inglis@URMC.Rochester.edu
Contact: Jennifer Reschke, M.S. 585-275-0690 Jennifer_Reschke@URMC.Rochester.edu

Locations
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United States, New York
Wilmot Cancer Center Recruiting
Rochester, New York, United States, 14642
Contact: Julia E Inglis, PhD         
Sponsors and Collaborators
University of Rochester

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Responsible Party: Julia Inglis, Research Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03897556     History of Changes
Other Study ID Numbers: 3607
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The information is not yet available to determine whether IPD should be made available to other researchers or not.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms