Effect of High-Dose Guarana And Cancer-Related Fatigue

NCT ID: NCT03897556

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-20

Study Completion Date

2022-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer-related Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a three-arm study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Guarana herb

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Guarana herb

Intervention Type 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

This arm receives usual-care only as cancer survivors.

Group Type OTHER

Usual Care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luke Peppone

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wilmot Cancer Center

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3607

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Creatine Supplementation in Chronic Fatigue Syndrome
NCT02374112 ACTIVE_NOT_RECRUITING NA