Phase I study of Effect of Cannabis in progression of cancer

Phase 1

Not yet recruiting

• Conditions: Malignant neoplasm of gallbladder. Ayurveda Condition: Cancers of gall bladder and hepatobiliary system, Oral and Breast ,

• Registration Number: CTRI/2023/03/050674
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

This is a phase 1 trial aimed at seing effect of cannabis on tumor cells and also to calculate a safe dose of cannabis. recuriment for trial has not start at ane we planned to start recurment from 1 /OCT/ 2021.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-14
• Study Start: 2023-03-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Histopathologically proven or clinic-radiologically diagnosed patients of liver, bile duct, gall bladder and pancreatic cancers.
• 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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess maximum tolerated dose at the dose limiting toxicity in hepatobiliary and pancreatic cancer	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MPMMCC; 🇮🇳 Varanasi, UTTAR PRADESH, India

MPMMCC

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Durgatosh Pandey

Principal investigator

9968722018

durgatosh@gmail.com