- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897556
Effect of High-Dose Guarana And Cancer-Related Fatigue
November 7, 2022 updated by: Luke Peppone, University of Rochester
The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14642
- Wilmot Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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.
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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.
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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.
|
Other: Usual Care
This arm receives usual-care only as cancer survivors.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey
Time Frame: Baseline to final visit (six weeks)
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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.
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Baseline to final visit (six weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Participants will bring in any leftover bars they don't consume during the study at midpoint and final assessments.
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Baseline to final visit (six weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2019
Primary Completion (Actual)
October 20, 2022
Study Completion (Actual)
October 21, 2022
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 7, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
The information is not yet available to determine whether IPD should be made available to other researchers or not.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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