RECRUITING

Effect of Kava on Anxiety and Stress in Cancer Survivors

Conditions

Kava Anxiety Stress Cancer Depression Sleep

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Kava on Anxiety and Stress in Cancer Survivors

Quick Facts

Study Start:2024-06-20

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06213298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Naomi Fujioka, MD

CONTACT

612-626-6689

fujio002@umn.edu

Study Locations (Sites)

Masonic Cancer Center

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: Masonic Cancer Center, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2024-06-20

Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

Kava
Anxiety
Stress
Cancer
Depression
Sleep