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

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.

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