Effect of Kava on Anxiety and Stress in Cancer Survivors

StatusWithdrawn
PhaseEarly Phase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Reclassified as withdrawn (was terminated)
    • Enrollment target: 1 to 0
    • Sponsor's reason: Drug expiration testing to Funding unavailable
  2. Suspended trial terminated Show 4 more changesShow less
    • Enrollment target: estimated 43 to confirmed 1
    • Primary completion date changed from estimate of Nov 30, 2027 to Oct 7, 2026
    • Study completion date changed from estimate of Nov 1, 2028 to Oct 7, 2026
    • Eligibility criteria expanded, about 18 words
  3. Trial status: Recruiting to Suspended Sponsor's reason: Drug expiration testing
    • Primary completion date: Nov 30, 2025 to Nov 30, 2027
    • Study completion date: Nov 1, 2026 to Nov 1, 2028
    • Site details revised
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2025 to Jun 20, 2024
    v6
  5. Start date: Feb 1, 2025 to Jun 1, 2025
    • Primary completion date: Jul 31, 2025 to Nov 30, 2025
    • Study completion date: Aug 1, 2026 to Nov 1, 2026
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Oct 1, 2024 to Feb 1, 2025v4
  2. Primary completion date: Jul 31, 2024 to Jul 31, 2025
    • Start date: Jun 1, 2024 to Oct 1, 2024
    • Study completion date: Aug 1, 2025 to Aug 1, 2026
    v3
  3. Start date: Mar 1, 2024 to Jun 1, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06213298
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions
(from sponsor)		 Kava, Anxiety, Stress, Cancer, Depression, Sleep
Related terms Anxiety Disorders, Depression, Neoplasms
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov