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Herbal Supplement

Usual Care for 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

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 weeks
Treatment ~ Varies
Follow Up ~baseline to final visit (six weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to final visit (six weeks) for reporting.

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 • NCT02008565
51%
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%
Hip fracture
1%
Breast cancer
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

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
859 Previous Clinical Trials
538,663 Total Patients Enrolled
10 Trials studying Fatigue
644 Patients Enrolled for Fatigue
~7 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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