Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified
Conditions
Interventions
Intervention1: Cannabis Sativa CBD or THC: Patient will be admitted for surgery and the Cap THC or CBD (7.5mg CBD and 7.5 mg THC) once a day starting 4 days before surgery and total of 5 doses will be
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Treatment na ve patients with radiologically suspected or histopathologically proven pancreatic cancer and periampullary carcinoma, undergoing curative intent treatment. 2.Age more than 18 and less 65 3.Valid informed consent 5.Non-metastatic 6.Undergoing curative surgery for operable pancreatic cancer and periampullary carcinoma(T1 to T3, N0 to N1, M0)
Exclusion criteria
Exclusion criteria: 1. Undergoing any other pre or peri-operative intervention such as neoadjuvant chemotherapy or radiotherapy 2. Presence of medical disease that may alter PKPD of cannabinoids such as pulmonary, renal, liver, gastro-intestinal disease which will interfere with any study specific procedure 3. Presence of uncontrolled cardiovascular disease, controlled hypertensives or diabetics will be allowed 4. History of substance abuse (including cannabis-related products) or alcohol abuse 5. Personal history of psychiatric disease 6. Significant family history of psychiatric disease 7. Pregnancy and or lactation. 8. Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc) 9. 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 10. Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study. 11.Any patient with positive HIV, HBsAg, HCV status
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate Disease-free survival (DFS) with perioperative cannabis as compared to standard treatment in patients undergoing pancreaticoduodenectomy for pancreatic cancer and periampullary carcinomaTimepoint: Disease free survival upto 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 5 years Overall Survival(OS)Timepoint: 5 years from the date of randomisation;To evaluate the safety and tolerability of preoperative cannabis.Timepoint: 2 hours, 4 hours, 6 hours, 12 hours and 24 hours after study drug administration;To assess the pathological response to preoperative cannabis.Timepoint: Immediately after surgery;To study the pharmacokinetics and pharmacodynamics of cannabisTimepoint: Blood collection will be done once pre-dose 30 mins, 1 hour, 2 hours, 4 hours and 8 hours post-dose. | — |
Countries
India
Contacts
Public ContactDr Manish Bhandare
TATA MEMORIAL HOSPITAL
Outcome results
None listed