Neuroendocrine TumorsPhase 2NCT07151391
The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers (Guarana Fatigue)
A Phase 2 study testing Guarana in people with Neuroendocrine Tumors and Gynecologic Cancer, run by University of Utah at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Gynecologic Cancer
- What is being tested?
- Guarana
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Or
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- ---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:
- ---Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
- Women < 50 years of age:
- ----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).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Amenorrhea for 24 months following cessation of all exogenous hormonal treatments, if applicable; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- 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.
- For the Gynecological Cancer cohort: Receiving any systemic treatment besides those listed in Inclusion 3-Cohort B (Gyn only) 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.
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- 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.
- Thromboembolic events (eg, deep venous thrombosis, pulmonary embolism) within 1 month before the first dose.
- QTc prolongation defined as a QTcF > 500 ms.
- Known congenital long QT.
- Uncontrolled hypertension per investigator assessment or grade 3 hypertension per CTCAE v.5.0
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the therapy through a feeding tube], social/ psychological issues, etc.)
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
- --Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
- --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
- Known hypersensitivity or allergy to investigational product (IP).
- Subjects taking prohibited medications as described in Section 6.6.2 or medications for which caffeine intake is contraindicated including: β-adrenergic agonists, and/or medications that contain pseudoephedrine. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Susan Sharry, 801-585-3453, susan.sharry@hci.utah.edu
Heloisa Soares, MD, 801-215-0501, erin.ward@hci.utah.edu
About this study
Official title: The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers
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
- Neuroendocrine Tumors, Gynecologic Cancer
- Being tested
- Guarana, Placebo
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuaranaDrug
Also called Paullinia cupana
500 mg oral medication daily
PlaceboDrug
Oral medication daily
| Study group | Role | What they receive |
|---|---|---|
| Guarana | Experimental | The study's goal is to determine the effect of Guarana on symptoms of fatigue Receives: Drug: Guarana |
| Placebo | Placebo comparator | The study's goal is to determine the effect of Guarana on symptoms of fatigue Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
To assess the safety and tolerability of guarana in the study population.
Measured: 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)
This outcome measure will report the sub-scales and single-item measures of the EORTC QLQ-C21NET for patients in the endometrial cohort
EORTC QLQ-C21NET will report 5 sub-scales (Endocrine, Gastrointestinal, Treatment-Related, Disease-Related Worries, Social Functioning) and 5 single-item measures (Weight Loss, Weight Gain, Muscle and/or Bone Pain, Information, Sexual Functioning)
All of 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.
Measured: 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)
This outcome measure will report the sub-scales and single-item measures of the EORTC QLQ-EN24 for patients in the endometrial cohort
EORTC QLQ-EN24 will report 7 sub-scales (Lymphoedema, Urological, Gastrointestinal, Poor body image, Sexual/vaginal problems, Tingling/numbness, Muscular pain) and 6 single-item measures (Sexual interest, Sexual activity, Sexual enjoyment, Pain in back and pelvis, Hair loss, Taste change)
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.
Measured: 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)
This outcome measure will report the sub-scales and single-item measures of the EORTC QLQ-OV28 for patients in the ovarian/fallopian tube cohort.
EORTC QLQ-OV28 reports 8 sub-scales (Abdominal/GI Scale, Peripheral Neuropathy, Hormonal, Body image, Attitude to disease/treatment, Hair Loss, Chemotherapy side effects, Sexuality) and 2 single-item measures (Indigestion or Heartburn, Taste)
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.
Measured: up to 5 week after initiation of study intervention
Subjective patient experience with guarana supplementation
This outcome will assess the subjective experience of participants with guarana supplementation. At the end of the study, participants will be asked: "How would you describe your experience with guarana supplementation?". Responses will be recorded using a three-point Likert scale (Positive, Neither positive or negative, or Negative).
This outcome measure will report the count of participants selecting each response category.
Measured: up to 5 week after initiation of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start3 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151391
- Sponsor's protocol ID
- HCI188422
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT07151391
- Acronym / sponsor ID
- HCI188422
- Conditions
- Neuroendocrine Tumors, Gynecologic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guarana | Experimental | Drug: GuaranaThe study's goal is to determine the effect of Guarana on symptoms of fatigue |
| Placebo | Placebo comparator | Drug: PlaceboThe study's goal is to determine the effect of Guarana on symptoms of fatigue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
- For the Gynecological Cancer cohort: Receiving any systemic treatment besides those listed in Inclusion 3-Cohort B (Gyn only) 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuaranaAlso: Paullinia cupana500 mg oral medication daily | Drug | Guarana |
| PlaceboOral medication daily | Drug | Placebo |
Primary outcome
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.
Time frame: up to 21 days after initiation of study intervention
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.
Stage 2 Change in EORTC QLQ-FA12 questionnaire scores from screening to days 21 and 42 of treatment.
Time frame: up to 42 days after initiation of study intervention
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.
5 secondary outcomes
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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: up to 5 week after initiation of study intervention
Subjective patient experience with guarana supplementation
Time frame: up to 5 week after initiation of study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Guarana in people with Neuroendocrine Tumors and Gynecologic Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Sharry (801-585-3453, susan.sharry@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 21 days after initiation of study intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.