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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
Study Summary
This trial will test whether a guaraná-based energy bar can help relieve cancer-related fatigue and improve physical performance, mood, and inflammation levels.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey
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.
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
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.
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Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,210 Total Patients Enrolled
10 Trials studying Fatigue
644 Patients Enrolled for Fatigue
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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