Effect of High-Dose Guarana And Cancer-Related Fatigue

• ClinicalTrials.gov Identifier: NCT03897556
• Recruitment Status: Recruiting
• First Posted: April 1, 2019
• Last Update Posted: November 4, 2021
• Sponsor: University of Rochester
• Information provided by (Responsible Party): Luke Peppone, University of Rochester

Study Description

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

Study Design

• 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: Supportive Care
• Official Title: The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors
• Actual Study Start Date: October 20, 2019
• Estimated Primary Completion Date: April 20, 2022
• Estimated Study Completion Date: April 21, 2023

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

More Information

• Responsible Party: Luke Peppone, Assistant Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03897556
• Other Study ID Numbers: 3607
• First Posted: April 1, 2019
• Last Update Posted: November 4, 2021
• Last Verified: November 2021

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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Fatigue