Effect of High-Dose Guarana And Cancer-Related Fatigue

University of Rochester

Status: Completed

Conditions: Cancer-related Fatigue

Treatments: Other: Usual Care; Dietary Supplement: Guarana herb

Study type: Interventional

Funder types: Other

Identifiers

NCT03897556

3607

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

High-dose

Active Comparator group

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.

Treatment:

Dietary Supplement: Guarana herb

Low-Dose

Active Comparator group

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.

Treatment:

Dietary Supplement: Guarana herb

Usual Care

Other group

Description:

This arm receives usual-care only as cancer survivors.

Treatment:

Other: Usual Care