RecruitingPhase 2

The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers (Guarana Fatigue)

United States86 participantsStarted 2025-09-03

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

--Subjects with unresected locally advanced or metastatic well differentiated neuroendocrine tumors who are either on a watch- and-wait approach or receiving treatment with somatostatin analog(s). Patient who received and completed another active treatment but are on a "break" from treatment will be allowed to enroll (e.g., patients that had completed PRRT).
--Subjects with early-stage (I or II) ovarian/fallopian-tube cancer in surveillance who have completed all treatment or are receiving adjuvant treatment.
--Subjects with endometrial cancer which is low risk, low-intermediate risk in surveillance, or high-intermediate risk receiving brachytherapy. Risk category is based on GOG criteria.
--Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula
---Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
---Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).

Exclusion criteria

-Note: Subjects with brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stage 1 Primary Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue 12 (EORTC QLQ-FA12) questionnaire scores from screening to Day 21 of guarana treatment.

Timeframe: up to 21 days after initiation of study intervention

Stage 2 Change in EORTC QLQ-FA12 questionnaire scores from screening to days 21 and 42 of treatment.

Timeframe: up to 42 days after initiation of study intervention

Trial details

NCT IDNCT07151391

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Susan Sharry

801-585-3453 susan.sharry@hci.utah.edu

View on ClinicalTrials.gov More Neuroendocrine Tumors trials