Status:
ACTIVE_NOT_RECRUITING
To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Breast Cancer
Oral Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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, w...
Detailed Description
The ancient Ayurvedic medicine obtained from Cannabis sativa plant has recently been re-explored for its anti-inflammatory and anti-cancer potential. Various laboratory and preclinical studies have pr...
Eligibility Criteria
Inclusion
- Histopathologically proven patients of breast or oral cavity SCC
- Age \> 18 and \< 65
- Operable cancers planned to undergo upfront curative surgery
- Patient fit for surgery (ASA Grade I / II)
- Patient Voluntarily willing to give consent for study
Exclusion
- Planned for any other pre or peri-operative intervention such as neoadjuvant chemotherapy or targeted therapy or radiation
- 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)
- History of substance abuse (including cannabis-related products) or alcohol abuse
- Personal history of psychiatric disease or Significant family history of psychiatric disease
- Pregnancy and/or lactation
- Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
- 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
- Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study
- Any patient with positive HIV, HBsAg, HCV status
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05969314
Start Date
June 8 2022
End Date
June 30 2025
Last Update
April 11 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Tata Memorial Center
Mumbai, Maharashtra, India, 400012
2
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012