NCT06213298

Effect of Kava on Anxiety and Stress in Cancer Survivors

• Status: Suspended
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Kava
• Anxiety
• Stress
• Cancer
• Depression
• Sleep

Interventions

Type	Name	Description
DRUG	Kava	75 mg kavalactones
DIETARY_SUPPLEMENT	Placebo	Placebo capsule

Timeline

• Start date: 2024-06-20
• Primary completion: 2027-11-30
• Completion: 2028-11-01
• First posted: 2024-01-19
• Last updated: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study