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Effect of High-Dose Guarana And Cancer-Related Fatigue

Primary Purpose

Cancer-related Fatigue

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Guarana herb

Usual Care

About this trial

This is an interventional supportive care trial for Cancer-related Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wilmot Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

High-dose

Low-Dose

Usual Care

Arm Description

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.

This arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only.

This arm receives usual-care only as cancer survivors.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03897556

First Posted

March 28, 2019

Last Updated

November 7, 2022

Sponsor

University of Rochester

1. Study Identification

Unique Protocol Identification Number

NCT03897556

Brief Title

Effect of High-Dose Guarana And Cancer-Related Fatigue

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 20, 2019 (Actual)

Primary Completion Date

October 20, 2022 (Actual)

Study Completion Date

October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer-related Fatigue

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

This is a three-arm study.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Low-Dose

Arm Type

Active Comparator

Arm Description

This arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only.

Arm Title

Usual Care

Arm Type

Other

Arm Description

This arm receives usual-care only as cancer survivors.

Intervention Type

Dietary Supplement

Intervention Name(s)

Guarana herb

Intervention Description

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

Other

Intervention Name(s)

Usual Care

Intervention Description

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 Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to final visit (six weeks)

Secondary Outcome Measure Information:

Title

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

Description

Participants will bring in any leftover bars they don't consume during the study at midpoint and final assessments.

Time Frame

Baseline to final visit (six weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Wilmot Cancer Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The information is not yet available to determine whether IPD should be made available to other researchers or not.

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Effect of High-Dose Guarana And Cancer-Related Fatigue

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