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Herbal Supplement
Effect of High-Dose Guarana And Cancer-Related Fatigue
N/A
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to final visit (six weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if guaraná energy bars can help reduce fatigue in cancer patients who have finished treatment. The bars may also improve physical performance, mood, and reduce inflammation. Guarana, a stimulant derived from an extract of seeds from a plant in the Amazon (Paullinia cupana), has shown potential benefits in improving fatigue scores in cancer patients.
Eligible Conditions
- Fatigue
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to final visit (six weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to final visit (six weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey
Secondary study objectives
The adherence to taking guarana energy bars: participant ate ≥ 80% of the guaraná energy bars assigned to them over the course of the study.
Side effects data
From 2016 Phase 3 trial • 300 Patients • NCT0200856551%
Constipation
9%
Urinary tract infection
6%
Diarrhoea
6%
Headache
5%
Fall
5%
Abdominal distension
5%
Abdominal pain
5%
Upper respiratory tract infection
3%
Nausea
2%
Haemorrhoids
1%
Breast cancer
1%
Hip fracture
1%
Syncope
1%
Medical device removal
1%
Back pain
1%
Animal bite
1%
Suture related complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Exercise Plus Biofeedback
Loperamide - Education Only
Placebo - Exercise Plus Biofeedback
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Usual CareExperimental Treatment1 Intervention
This arm receives usual-care only as cancer survivors.
Group II: High-doseActive Control1 Intervention
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 III: Low-DoseActive Control1 Intervention
This arm consists of cancer survivors who receive one guarana energy bar to take per day for six weeks; one in the morning only.
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
871 Previous Clinical Trials
549,778 Total Patients Enrolled
10 Trials studying Fatigue
644 Patients Enrolled for Fatigue