Actively Recruiting
The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers (Guarana Fatigue)
Led by University of Utah · Updated on 2026-02-10
86
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to learn if the drug guarana improves symptoms of fatigue in patients with neuroendocrine tumors and gynecologic cancers
CONDITIONS
Official Title
The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers (Guarana Fatigue)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- For Neuroendocrine Tumor cohort: patients with unresected locally advanced or metastatic well differentiated neuroendocrine tumors on watch-and-wait or somatostatin analog treatment, or on treatment break after prior active therapy
- For Gynecologic Cancer cohort: patients with early-stage ovarian or fallopian-tube cancer in surveillance or receiving adjuvant treatment
- For Gynecologic Cancer cohort: patients with low to high-intermediate risk endometrial cancer in surveillance or receiving brachytherapy
- ECOG Performance Status of 2 or less
- Fatigue score of 4 or higher on NCCN screening questions within 4 weeks before randomization
- Adequate organ function including hemoglobin ≥ 9 g/dL, bilirubin ≤ 1.5x ULN (or ≤ 3x ULN with liver involvement), AST/ALT ≤ 3x ULN (≤ 5x ULN if liver metastases), and creatinine clearance ≥ 30 mL/min
- For females: negative pregnancy test or post-menopausal status as defined by specific hormone levels, amenorrhea duration, or surgical sterilization
- Females of childbearing potential and males with partners of childbearing potential must use effective contraception
- Able and willing to provide informed consent
You will not qualify if you...
- Neuroendocrine Tumor cohort: receiving cytotoxic chemotherapy, radiation, PRRT, or TKIs within 6 weeks before starting study treatment
- Gynecologic Cancer cohort: receiving systemic treatments not listed in inclusion within 6 weeks before starting study treatment
- Untreated or uncontrolled endocrine disorders impacting participation
- Significant autoimmune disease affecting study involvement
- Use of guarana supplements within 2 months of consent
- Self-reported caffeine sensitivity with symptoms likely to interfere with participation
- Concurrent use of psychostimulant medications
- Major surgery within 4 weeks before starting study therapy or not fully recovered from surgery
- Diagnosis of other malignancies that may affect safety or study goals
- Known brain metastases or cranial epidural disease unless treated, stable for 4 weeks, asymptomatic, and off corticosteroids
- Uncontrolled serious illnesses including certain heart conditions, recent strokes or thromboembolic events, prolonged QTc interval, uncontrolled hypertension
- Known HIV infection with detectable viral load within 6 months before treatment (patients on effective therapy with undetectable viral load are eligible)
- Active infections including tuberculosis, hepatitis B or C unless resolved or controlled as defined
- Medical, psychiatric, or cognitive conditions limiting ability to consent or comply with study
- Known allergy to the investigational product
- Use of prohibited medications or medications contraindicated with caffeine without sufficient washout
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
S
Susan Sharry
CONTACT
E
Erin Ward, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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