RECRUITING

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

Conditions

Neuroendocrine Tumors Gynecologic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-09-03

Study Completion:2028-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07151391

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects aged ≥ 18 years. * Cohort A (Neuroendocrine Tumor) Only: * Cohort B (Gynecological Cancer) Only: * Or * 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) * 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: * 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. The following age-specific requirements apply: * Women \< 50 years of age: * 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.	* 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 hypothyroidism (TSH must be within institutional normal limits for age). * History of significant autoimmune disease in the opinion of the investigator that is likely to 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. * Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions: * 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. * 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. * 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.

Inclusion Criteria

Exclusion Criteria

* Subjects aged ≥ 18 years.
* Cohort A (Neuroendocrine Tumor) Only:
* Cohort B (Gynecological Cancer) Only:
* Or
* 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)
* 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:
* 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. The following age-specific requirements apply:
* Women \< 50 years of age:
* 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.

* 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 hypothyroidism (TSH must be within institutional normal limits for age).
* History of significant autoimmune disease in the opinion of the investigator that is likely to 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.
* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
* 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.
* 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.
* 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.

Contacts and Locations

Study Contact

Susan Sharry

CONTACT

801-585-3453

susan.sharry@hci.utah.edu

Erin Ward, MD

CONTACT

801-585-0236

erin.ward@hci.utah.edu

Study Locations (Sites)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03

Study Completion Date2028-09

Study Record Updates

Study Start Date2025-09-03

Study Completion Date2028-09

Terms related to this study

Additional Relevant MeSH Terms

Neuroendocrine Tumors
Gynecologic Cancer