Status:
RECRUITING
Effect of Kava on Anxiety and Stress in Cancer Survivors
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Kava
Anxiety
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06213298
Start Date
June 20 2024
End Date
November 1 2026
Last Update
March 18 2025
Active Locations (1)
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1
Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455