Effect of Kava on Anxiety and Stress in Cancer Survivors

NCT06213298 | Suspended Early Phase 1 DMC FDA Drug

• 1 other identifier: HOT-2023-30373
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Depression; Sleep; Kava; Anxiety; Stress

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Kava

EXPERIMENTAL

75mg of Kava taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days.

Drug: Kava

Placebo

PLACEBO COMPARATOR

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

Interventions

Kava DRUG

75 mg kavalactones

Kava

Placebo DIETARY_SUPPLEMENT

Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Neoplasms; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)