Effect of High-Dose Guarana And Cancer-Related Fatigue

Not Applicable

Completed

• Conditions: Cancer-related Fatigue
• Interventions: Dietary Supplement: Guarana herb; Other: Usual Care

• Registration Number: NCT03897556
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-03-28
• Study First Posted: 2019-04-01
• Study Start: 2019-10-20
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Dose	Guarana herb	This arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only.
High-dose	Guarana herb	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.
Usual Care	Usual Care	This arm receives usual-care only as cancer survivors.

Primary Outcome Measures

Name	Time	Method
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey	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

Name	Time	Method
The adherence to taking guarana energy bars: participant ate ≥ 80% of the guaraná energy bars assigned to them over the course of the study.	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.

Trial Locations

Locations (1)

Wilmot Cancer Center; 🇺🇸 Rochester, New York, United States