Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Oral cannabis paste: Bhanga (Cannabis sativa)is a main ingrediant of the formulation along with total of 57 Herbomineral drugs paste. This is the standard cannabis preparation used in a
Sponsors
Tata Memorial Centre
Not any
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histopathologically proven patients of oral cavity SCC 2.Age between 18 to 65 years 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
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 |
|---|---|
| Biomarker analysis- Effect of oral cannabis on transcriptomic profiling of the tumourTimepoint: 1.Day 1 Biopsy before drug administration 2. Day 22 Biopsy before surgery, tissue sample from tumor midway between surgery and after surgery from removed cancer tissues | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To establish a pharmacokinetic profile of ayurvedic oral cannabis preparationTimepoint: 1.on Day 1- Blood collection before drug aministration and 30 min,1hr, 2hr, 4hr and 8 hrs after doseing 2.On day 21- Blood collection before drug aministration and 30 min,1hr, 2hr, 4hr and 8 hrs after doseing 3.blood collection on Post operation on day 1, day 2, day 3 and day 14 ;3.To look at the PK and SE profile.Timepoint: 1.on Day 1- Blood collection before drug aministration and 30 min,1hr, 2hr, 4hr and 8 hrs after doseing 2.On day 21- Blood collection before drug aministration and 30 min,1hr, 2hr, 4hr and 8 hrs after doseing 3.blood collection on Post operation on day 1, day 2, day 3 and day 14 | — |
Countries
India
Contacts
Public ContactDr Shivakumar Thiagarajan
Tata Memorial Hospital
Outcome results
None listed