Anxiety, Cancer, Depression, Kava, Sleep, Stress
Conditions
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 and its treatment. Participants will be randomized to take either kava first or placebo first. Kava 75 mg or placebo will be taken three time daily (TID) for 14 days (Period 1), followed by a washout period of 14-28 days. Thereafter, the participant will take either placebo or kava TID for 14 days (Period 2), whichever he/she did not take in Period 1.
Interventions
DRUGKava
75 mg kavalactones
DIETARY_SUPPLEMENTPlacebo
Placebo capsule
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS anxiety measure score after 14 days of kava or placebo | 14 days | PROMIS- 29 questionnaire will be administered to determine anxiety level. Scale 4-20. Higher score indicates higher anxiety. |
| Incidence of adverse events attributable to kava | 14 days | Assessed using CTCAE v5.0 |
Countries
United States
Outcome results
None listed