NCT03897556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

March 28, 2019

Last Update Submit

November 7, 2022

Conditions

Cancer-related Fatigue

Outcome Measures

Primary Outcomes (1)

  • 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 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.

    Baseline to final visit (six weeks)

Study Arms (3)

High-dose

ACTIVE COMPARATOR

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.

Dietary Supplement: Guarana herb

Low-Dose

ACTIVE COMPARATOR

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

Dietary Supplement: Guarana herb

Usual Care

OTHER

This arm receives usual-care only as cancer survivors.

Other: Usual Care

Interventions

Guarana herbDIETARY_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.

High-doseLow-Dose
Usual CareOTHER

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.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a three-arm study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 1, 2019

Study Start

October 20, 2019

Primary Completion

October 20, 2022

Study Completion

October 21, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

US(1)