Phase I study of Effect of Cannabis in progression of cancer

Phase 1

• Conditions: Health Condition 1: C23- Malignant neoplasm of gallbladder

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Histopathologically proven or clinic-radiologically diagnosed patients of liver, bile

duct, gall bladder and pancreatic cancers.

2. 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified