Suspended

Kava's Impact on Anxiety and Stress in Cancer Survivors

Study Aim

This early phase study aims to evaluate the impact of Kava on anxiety and stress in cancer survivors, by observing changes in the PROMIS anxiety measure score after 14 days of Kava or placebo, and monitoring the incidence of adverse events attributable to Kava.

What is being tested

Kava

+ Placebo

DrugDietary Supplement

Who is being recruted

Anxiety Disorders+3

+ Behavior

+ Mental Disorders

Over 18 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Placebo-ControlledEarly Phase 1

Interventional

Study Start: June 2024

See protocol details

Summary

Principal SponsorMasonic Cancer Center, University of Minnesota

Last updated: February 12, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 20, 2024

Actual date on which the first participant was enrolled.

This study is focused on understanding how kava, a plant-based supplement, can help reduce anxiety and stress in people who have survived cancer and its treatment. Cancer survivors often deal with ongoing stress and anxiety, which can affect their quality of life. By investigating the effects of kava, the study aims to discover a potential way to provide relief and improve well-being for those who have completed cancer treatment. Participants in the study will be randomly assigned to take kava or a placebo, which is a harmless pill with no active ingredients, three times a day for 14 days. After this period, there is a break of up to 28 days where no pills are taken. Then, participants switch to the opposite treatment—those who took kava now take the placebo, and vice versa, for another 14 days. This crossover design helps researchers compare the effects of kava against the placebo in the same individuals. The goal is to see if kava can safely reduce anxiety and stress, potentially offering a new supportive care option for cancer survivors.

Official TitleEffect of Kava on Anxiety and Stress in Cancer Survivors

NCT06213298

Principal SponsorMasonic Cancer Center, University of Minnesota

Last updated: February 12, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

43 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersBehaviorMental DisordersBehavioral SymptomsDepressionNeoplasms

Criteria

6 inclusion criteria required to participate

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

Show More Criteria

12 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Placebo

The placebo will be taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Masonic Cancer Center

Minneapolis, United StatesOpen Masonic Cancer Center in Google Maps

SuspendedOne Study Center