Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
None listed
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histopathologically proven or clinic-radiologically diagnosed patients of liver, bile duct, gall bladder and pancreatic cancers. 2. Age > 18 and 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 |
|---|---|
| Assess maximum tolerated dose at the dose limiting toxicity in hepatobiliary and pancreatic cancerTimepoint: Day 1, day 2, day 3, day 4, day 5, before beginning the surgery , at the end of surgery, post operation day 1, post operation day 2, post operation day 3, post operation day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To establish a pharmacokinetic profile of oral cannabis preparation 2.To study the PK and SE profile for continuation into phase 2 and 3 study 3.Biomarker analysis- Effect of oral cannabis on transcriptomic profiling of the tumour Timepoint: Day 1, day 2, day 3, day 4, day 5, before beginning the surgery , at the end of surgery, post operation day 1, post operation day 2, post operation day 3, post operation day 14. | — |
Countries
India
Contacts
Public ContactDr Mayanak Tripathi
MPMMCC HBCH Varanasi
Outcome results
None listed