Effect of Kava on Anxiety and Stress in Cancer Survivors

Depression Clinical Trial

Official title:

Effect of Kava on Anxiety and Stress in Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213298
• Other study ID #: HOT-2023-30373
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Naomi Fujioka, MD
• Phone: 612-626-6689
• Email: fujio002[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: August 1, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Sleep
• Stress

Intervention

Drug:
• Kava
75 mg kavalactones

Dietary Supplement:
• Placebo
Placebo capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of adverse events attributable to kava	Assessed using CTCAE v5.0	14 days