Effect of Kava on Anxiety and Stress in Cancer Survivors

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how kava, a natural supplement, might help reduce anxiety and stress in people who have survived cancer. The study involves two groups of participants who will take either kava or a placebo (a dummy pill with no active ingredients) for 14 days. A placebo is used to compare the effects of kava. After a break period, participants will switch to the other treatment for another 14 days. The trial aims to see if kava can safely help improve feelings of anxiety and stress in cancer survivors.

To be eligible for this study, participants should have completed their cancer treatment within the last two years and have mild anxiety. They should also be in generally good health, with normal kidney and liver function, and be willing to avoid certain medications like benzodiazepines (often used for anxiety) and alcohol during the study. Participants can expect to take kava or a placebo three times a day for two weeks, with regular check-ins to monitor their health and well-being. This trial is currently recruiting and welcomes all genders aged 65 to 74 who meet the criteria.

Gender

ALL

Eligibility 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