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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
43
Masonic Cancer Center
Minneapolis, Minnesota, United States
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.
Time frame: 14 days
Incidence of adverse events attributable to kava
Assessed using CTCAE v5.0
Time frame: 14 days
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