Skip to main content
OpenTrials
Completed

NCT Number: NCT03897556

Effect of High-Dose Guarana And Cancer-Related Fatigue

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer-related Fatigue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilmot Cancer Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guarana herb

Dietary Supplement

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

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2019
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.