Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Masonic Cancer Center, University of Minnesota
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Completed curative-intent treatment for breast, gynecologic, lung, or head/neck cancer within the last 24 months without clinical and/or radiographic evidence of recurrence at the time of the last follow up
Score of ≥ 5 on the GAD-7 questionnaire, considered to be mild anxiety
ECOG performance status 0-1
Normal kidney and liver function within 28 days prior to the first dose of kava or placebo
Willing to abstain from benzodiazepine and alcohol use during the kava or placebo intervention and for at least 14 days after completion
Ability to provide written, informed consent
You may not be if
Regular use of benzodiazepines, defined as ≥ 2 times weekly, within 14 days prior to study registration
Anti-cancer therapy within 28 days prior to registration, and/or during study participation, except for aromatase inhibitors
Known liver disease such as cirrhosis (any Child-Pugh class), active infectious hepatitis, immune-mediated hepatitis, hemochromatosis, non-alcoholic steatohepatitis (NASH), or Wilson's disease
Use of acetaminophen at doses more than 2000 mg daily for more than three days per week within 7 days prior to the first dose of kava or placebo intervention
Chronic use of high-intensity statin therapy
Significant uncontrolled conditions or situations, which in the judgment of the enrolling investigator, could affect safety and/or ability to adhere to study requirements
Adjustments in anti-depressants and/or anxiolytic medications within 8 weeks prior to study registration
Known allergy to kava
Women who are pregnant, intend to become pregnant, or are nursing
Regular use of alcohol, defined as ≥ 3 times per week, regardless of amount, within 14 days prior to study registration
Parkinson's disease
History of or current substance use disorder by self-report
Clareo Health | Effect of Kava on Anxiety and Stress in Cancer Survivors
