Effect of Kava on Anxiety and Stress in Cancer Survivors

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.

Study Overview

• Status: Suspended
• Conditions: Depression; Cancer; Stress; Sleep; Anxiety; Kava
• Intervention / Treatment: Dietary supplement: Placebo; Drug: Kava

• Study Type: Interventional
• Enrollment (Estimated): 43
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kava; 75mg of Kava taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days.	Drug: Kava; 75 mg kavalactones
Placebo Comparator: Placebo; The placebo will be taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days.	Dietary supplement: Placebo; Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PROMIS anxiety measure score after 14 days of kava or placebo	PROMIS- 29 questionnaire will be administered to determine anxiety level. Scale 4-20. Higher score indicates higher anxiety.	14 days
Incidence of adverse events attributable to kava	Assessed using CTCAE v5.0	14 days

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Neoplasms; Anxiety Disorders; Depression
• Other Study ID Numbers: HOT-2023-30373

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data will be shared amongst the study team via Box.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No