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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Guarana
Drug500 mg oral medication daily
Placebo
DrugOral medication daily
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: GuaranaExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 21 days after initiation of study intervention2
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.
Time frame
up to 42 days after initiation of study interventionSecondary outcomes
1
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.
Time frame
up to 5 week after initiation of study intervention2
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.
Time frame
up to 5 week after initiation of study intervention3
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.
Time frame
up to 5 week after initiation of study intervention4
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.
Time frame
up to 5 week after initiation of study interventionSponsors and contacts
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Source ClinicalTrials.gov