KavaEarly Phase 1NCT06213298
Effect of Kava on Anxiety and Stress in Cancer Survivors
A Early Phase 1 study testing Kava in people with Kava and Anxiety, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Kava
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 7 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Kava, Placebo
- Medical subject headings
- Anxiety Disorders, Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KavaDrug
75 mg kavalactones
PlaceboDietary supplement
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Kava | Experimental | 75mg of Kava taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Incidence of adverse events attributable to kava
Assessed using CTCAE v5.0
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start20 Jun 2024
- Primary completion7 Oct 2026
- Study completion7 Oct 2026
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KavaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213298
- Sponsor's protocol ID
- HOT-2023-30373
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be shared amongst the study team via Box.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kava on Anxiety and Stress in Cancer Survivors
- ClinicalTrials.gov ID
- NCT06213298
- Acronym / sponsor ID
- HOT-2023-30373
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 7 Oct 2026 (actual)
- Study completion
- 7 Oct 2026 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kava | Experimental | Drug: Kava75mg of Kava taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo will be taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kava75 mg kavalactones | Drug | Kava |
| PlaceboPlacebo capsule | Dietary supplement | Placebo |
Primary outcome
Change in PROMIS anxiety measure score after 14 days of kava or placebo
Time frame: 14 days
PROMIS- 29 questionnaire will be administered to determine anxiety level. Scale 4-20. Higher score indicates higher anxiety.
Incidence of adverse events attributable to kava
Time frame: 14 days
Assessed using CTCAE v5.0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. De-identified data will be shared amongst the study team via Box.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Kava in people with Kava and Anxiety, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS anxiety measure score after 14 days of kava or placebo (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.