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
• Subjects aged ≥ 18 years.
• Cohort A (Neuroendocrine Tumor) Only:
⁃ --Subjects with 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 with platinum-based chemotherapy +/- maintenance therapy with PARP inhibitor(s) or bevacizumab.
• Or
⁃ --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)
∙ 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. 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.