To Check Safety of Ayurvedic Oral Cannabis in Breast and Head and Neck Cancer
Breast Cancer, Oral Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Tata Memorial Center
- Tata Memorial Hospital
Arms of the Study
Arm 1
Experimental
Cannabis
Cannabis capsules containing 5 mg of THC and CBD each or 2.5 mg of THC and CBD each.