A phase one study to evaluate safety and usefulness of a Ayurvedic cannabis medication administered orally in breast and oral cavity cancers.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Histopathologically proven patients of breast or oral cavity SCC

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

Primary Outcome Measures

Name	Time	Method
To establish a Safety and pharmacokinetic profile of oral cannabis preparationTimepoint: 1. Pre operative day 1 to day 5 - On each day- before cannabinoid doseing, after dosing 30 min, 1hr, 2hr, 4hr, and 8hrs after dosing <br/ ><br>2. On a day of surgery- before and after the surgery <br/ ><br>3. Post operative period- post operat day 1, day2, day3 and day 14

Secondary Outcome Measures

Name	Time	Method
Assess maximum tolerated dose at the dose limiting toxicityTimepoint: 1. Pre operative day 1 to day 5 - On each day- before cannabinoid doseing, after dosing 30 min, 1hr, 2hr, 4hr, and 8hrs after dosing <br/ ><br>2. On a day of surgery- before and after the surgery <br/ ><br>3. Post operative period- post operat day 1, day2, day3 and day 14;Biomarker analysis- Effect of oral cannabis on transcriptomic profiling of the tumourTimepoint: A baseline tumor sample day 0, Tumour tissue samples will be collected just before, midway through, and at the end of the surgical procedure