Kava's effects on anxiety and stress in cancer survivors
Effect of Kava on Anxiety and Stress in Cancer Survivors
This study is testing if kava can help reduce anxiety and stress in cancer survivors who finished treatment in the last two years.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Masonic Cancer Center, University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06213298 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial investigates the safety and efficacy of kava in reducing anxiety and physiological stress among cancer survivors. Participants will be randomly assigned to receive either kava or a placebo for 14 days, followed by a washout period before switching to the alternative treatment. The study aims to assess the impact of kava on anxiety levels, measured using the GAD-7 questionnaire, in individuals who have completed cancer treatment within the last 24 months.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors who have completed treatment for specific cancers within the last 24 months and experience mild anxiety.
Not a fit: Patients currently using benzodiazepines or undergoing anti-cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-pharmacological option for managing anxiety and stress in cancer survivors.
How similar studies have performed: While the use of kava for anxiety is explored in other contexts, this specific application in cancer survivors is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Minneapolis, Minnesota
- Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Naomi Fujioka, MD
- Email: fujio002@umn.edu
- Phone: 612-626-6689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.