A Phase 2 pilot study to test the effectiveness of Ayurvedic oral cannabis medication administered orally in oral cavity cancer.

Phase 2

• Conditions: Health Condition 1: C069- Malignant neoplasm of mouth, unspecified

• Registration Number: CTRI/2023/07/055915
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.Histopathologically proven patients of oral cavity SCC, all stages (non-metastatic)

2.Operable cancers planned to undergo upfront curative surgery

3.Patient fit for surgery (ASA Grade I / II)

4.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