Clinical trial NCT06213298: Effect of Kava on Anxiety and Stress in Cancer Survivors
Official title: Effect of Kava on Anxiety and Stress in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Kava
Anxiety
Stress
Cancer
Depression
Sleep
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in PROMIS anxiety measure score after 14 days of kava or placebo
timeFrame: 14 days
measure: Incidence of adverse events attributable to kava
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center
state: Minnesota
Study officials:
References: