The Use of Guarana to Treat Fatigue in Patients With Neuroendocrine Tumors and Gynecologic Cancers (Guarana Fatigue)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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
Eligibility criteria
Qualifiers
Subjects aged ≥ 18 years.
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Guarana
- Placebo
Treatment groups
86 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov