Health Condition 1: C069- Malignant neoplasm of mouth, unspecified
Conditions
Interventions
Intervention1: Capsule of cannabinoid compounds: The Ayurvedic preparation will be provided by Sai Phytoceuticals Pvt Ltd in their AYUSH and
WHO approved GMP facility. The investigational product is
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histopathologically proven patients of oral cavity SCC, all stages (non-metastatic) 2.Operable cancers planned to undergo upfront curative surgery 3.Patient fit for surgery (ASA Grade I / II) 4.Patient Voluntarily willing to give consent for study
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect (Bio marker analysis) of cannabis with 3 different proportions of THC: CBD on the transcriptomic profiling of tumour. Timepoint: 1.A baseline tumour tissue biopsy predose 2.Tumour tissue samples will be collected just before, midway through & at the end of the surgical procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To establish a pharmacokinetic profile of ayurvedic oral cannabis preparation 2. QoL of these patients Timepoint: 1.Preoperative day 1 & on day 5 before cannabinoid dosing, after 30 min, 1 hr, 2 hr, 4 hr, & 8 hr after dosing 2. On a day of surgery-before and after surgery 3.Post operative period- post operate day 1, day 2, day 3 and day 14 | — |
Countries
India
Contacts
Public ContactDr Shivakumar Thiagarajan
Tata Memorial Centre
Outcome results
None listed