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To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
Sponsor: Tata Memorial Hospital
Summary
Phase 1 study to assess the pharmacokinetic availability and safety and tolerability profile of one such ayurvedic preparation which contains 5 mg THC:CBD 1:1 preparation. Other than the PK profile, we will also be studying its effect on gene expression profiling of the breast and head neck oral cavity squamous cell carcinoma tissue.
Official title: Phase I Study of Safety and Feasibility of Ayurvedic Oral Cannabis Preparation in the Peri-operative Period in Breast and Oral Cavity Squamous Cell Cancer
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2022-06-08
Completion Date
2025-06-30
Last Updated
2025-04-11
Healthy Volunteers
No
Conditions
Interventions
Cannabis capsules
Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.
Locations (2)
Tata Memorial Center
Mumbai, Maharashtra, India
Tata Memorial Hospital
Mumbai, Maharashtra, India