Ireland
--:--IST
Active, not recruiting Phase 1

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

NCT05969314 · tracked via the Priya Life Science India tracker
Phase
Phase 1
Started
2022-06-08
Last updated
2026-10-02

Condition(s) studied

Breast CancerOral Cancer

Investigational drug(s) / intervention(s)

Cannabis capsules →

Cannabis capsules: Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histopathologically proven patients of breast or oral cavity SCC 2. Age \> 18 and \< 65 3. Operable cancers planned to undergo upfront curative surgery 4. Patient fit for surgery (ASA Grade I / II) 5. Patient Voluntarily willing to give consent for study Exclusion Criteria: 1. Planned for any other pre or peri-operative intervention such as neoadjuvant chemotherapy or targeted therapy or radiation 2. Presence of medical disease such as pulmonary, renal, liver, gastro-intestinal disease which may interfere with any study specific procedure (deranged renal parameters \> 1.5 times normal range or deranged liver function tests such as \> 2.5 times raised liver enzymes) 3. History of substance abuse (including cannabis-related products) or alcohol abuse 4. Personal history of psychiatric disease or Significant family history of psychiatric disease 5. Pregnancy and/or lactation 6. Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc) 7. Patients on other medications which will likely have a drug interaction with cannabis- such as clozapine, duloxetine, naproxen, cyclobenzaprine, olanzapine, haloperidol, and chlorpromazine, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil (and other PDE5 inhibitors), antihistamines, haloperidol, antiretrovirals 8. Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study 9. Any patient with positive HIV, HBsAg, HCV status

Primary outcome measure(s)

  • To establish safe dose of oral cannabis preparation — From day 1 of IP dosing till 28 days .
    Number of participants with treatment-related adverse events with respect to cardiovascular, central nervous system and psychotropic of cannabis as assessed by CTCAE v4.0

Trial sites (2)

FacilityCityRegionStatus
Tata Memorial Center Mumbai Maharashtra
Tata Memorial Hospital Mumbai Maharashtra
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05969314 on ClinicalTrials.gov ↗ ← All trials in India