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

NCT07151391 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HCI188422
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gynecologic Cancer; Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• 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.

  To assess the use of guarana to improve symptoms of fatigue in patients with NETs and Gynecologic (Ovarian/Fallopian Tube and Endometrial) cancers and to estimate the Cohen's effect size for planning of the randomized controlled trial in stage II. This outcome measure will report 3 sub-scales (Physical Fatigue Score, Emotional Fatigue Score, and Cognitive Fatigue Score) and two single-item measures (Interference with daily life and Social sequelae score). All of the scales and single-item measures range in score from 0 to 100. For all the scales and single items, a high score represents a high level of symptomatology or problems.

  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.

  To evaluate if the EORTC QLQ-FA12 score changes from baseline to Day 21 and 42 days differs between the guarana treated arm and the placebo arm. This outcome measure will report 3 sub-scales (Physical Fatigue Score, Emotional Fatigue Score, and Cognitive Fatigue Score) and two single-item measures (Interference with daily life and Social sequelae score). All of the scales and single-item measures range in score from 0 to 100. For all the scales and single items, a high score represents a high level of symptomatology or problems.

  up to 42 days after initiation of study intervention

Secondary Outcomes (5)

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.

  up to 5 week after initiation of study intervention

• Quality of Life (QoL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Neuroendocrine Tumors (EORTC QLQ-GINET21)

  up to 5 week after initiation of study intervention

• Quality of Life (QoL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module 24 (EORTC QLQ-EN24)

  up to 5 week after initiation of study intervention

• Quality of Life (QoL) - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer 28 (EORTC QLQ-OV28)

  up to 5 week after initiation of study intervention

• Subjective patient experience with guarana supplementation

  up to 5 week after initiation of study intervention

Study Arms (2)

Guarana

EXPERIMENTAL

The study's goal is to determine the effect of Guarana on symptoms of fatigue

Drug: Guarana

Placebo

PLACEBO COMPARATOR

The study's goal is to determine the effect of Guarana on symptoms of fatigue

Drug: Placebo

Interventions

Guarana DRUG

500 mg oral medication daily

Also known as: Paullinia cupana

Guarana

Placebo DRUG

Oral medication daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged ≥ 18 years.
• Cohort A (Neuroendocrine Tumor) Only:
• 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).
• Cohort B (Gynecological Cancer) Only:
• 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.
• ECOG Performance Status ≤ 2.
• Documentation of a score of 4 or higher when answering either of the NCCN-recommended screening questions ("How exhausted do you feel on a scale of 0 to 10?" or "How impaired do you feel by this fatigue on a scale of 0 to 10?") within 4 weeks prior to randomization
• Adequate organ function as defined as:
• Hematologic:
• Hemoglobin ≥ 9 g/dL
• Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) or ≤3 x ULN with documented liver involvement and/or Gilbert's disease
• AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Subjects with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
• Renal:

You may not qualify if:

• For the Neuroendocrine Tumor cohort: Receiving treatment with Cytotoxic Chemotherapy, Radiation Therapy, PRRT or TKIs within 6 weeks prior to the first dose of study treatment.
• Untreated or uncontrolled endocrinopathy which is likely to significantly impact study participation.
• History of significant autoimmune disease in the opinion of the investigator that is likely to significantly impact study participation.
• Prior use of guarana supplements within two months of consent.
• Self-reported "caffeine sensitivity" defined as excessive unwanted feelings of anxiousness, jitteriness, difficulty sleeping, or anxiety after caffeine exposure, which in the opinion of the Investigator is likely to negatively impact study participation.
• Concurrent use of psychostimulants (e.g., lisdexamfetamine, methylphenidate).
• Major surgery within 4 weeks prior to starting study therapy or subjects who have not fully recovered from major surgery.
• The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or study aims.
• Known brain metastases or cranial epidural disease.
• 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.
• Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
• Cardiovascular disorders:
• Significant symptomatic carcinoid heart disease in the opinion of the investigator
• Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
• Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic events) within 3 months before the first dose.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

guarana powder

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Susan Sharry

CONTACT

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

Erin Ward, MD

CONTACT

801-585-0236; erin.ward@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 3, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)