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To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Jun 30, 2025 → Dec 30, 2026
See other at-risk trials from Tata Memorial Hospital

Record History

  1. Notable Primary and study completion pushed from Jun 30, 2025 to Dec 30, 2026 Eligibility criteria expanded, about 14 words · Publications: details revised at 27 of 27 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Publications: details revised at 27 of 27 entries
  2. Notable Primary completion date: Dec 31, 2024 to Jun 30, 2025v3
  3. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2024 Completion date: Dec 31, 2023 to Jun 30, 2025v2 Show 1 more changeShow less
    • Completion date: Dec 31, 2023 to Jun 30, 2025
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05969314
Lead Sponsor Tata Memorial Hospital
Conditions Breast Cancer, Oral Cancer
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov