Effect of Kava on Anxiety and Stress in Cancer Survivors

Trial Title: Effect of Kava on Anxiety and Stress in Cancer Survivors

NCT ID: NCT06213298

Condition: Kava
Anxiety
Stress
Cancer
Depression
Sleep

Conditions: Official terms:
Anxiety Disorders

Study type: Interventional

Study phase: Early Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Kava
Description: 75 mg kavalactones
Arm group label: Kava

Intervention type: Dietary Supplement
Intervention name: Placebo
Description: Placebo capsule
Arm group label: Placebo

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: February 1, 2025

Completion date: August 1, 2026

Lead sponsor:
Agency: Masonic Cancer Center, University of Minnesota
Agency class: Other

Source: Masonic Cancer Center, University of Minnesota

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06213298