Effect of High-Dose Guarana And Cancer-Related Fatigue

Cancer-related Fatigue Clinical Trial

Official title:

The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03897556
• Other study ID #: 3607
• Status: Completed
• Phase: N/A
• Start date: October 20, 2019
• Est. completion date: October 21, 2022

Study information

• Verified date: November 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 21, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: ß-adrenergic agonists, and/or medications that contain pseudoephedrine.

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Wilmot Cancer Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey	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.	Baseline to final visit (six weeks)
Secondary	The adherence to taking guarana energy bars: participant ate = 80% of the guaraná energy bars assigned to them over the course of the study.	Participants will bring in any leftover bars they don't consume during the study at midpoint and final assessments.	Baseline to final visit (six weeks)