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Effect of Kava on Anxiety and Stress in Cancer Survivors

NCT06213298 · Status: SUSPENDED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-02-11

No results posted yet for this study

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

Interventions

DRUG

Kava

75 mg kavalactones

DIETARY_SUPPLEMENT

Placebo

Placebo capsule

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2027-11-30
Completion
2028-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06213298 on ClinicalTrials.gov