A study to evaluate the effect of cannabis(a plant extract) used in a form of vapors before the surgery on clinical and gene expression in breast cancer patients. CABREX STUDY

Not Applicable

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2020/12/029967
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1)Women histopathologically proven to have breast cancer (FNAC/core biopsy/incision biopsy)

2)Age > 18 and < 65

3)Valid, informed consent

4)Non-metastatic

5)Those who have not received any treatment including Neo-adjuvant chemotherapy or hormonal therapy

6)Undergoing curative surgery for operable breast cancer (T1-4, N0-2, M0)

Exclusion Criteria

1) Undergoing any other pre or peri-operative intervention such as neoadjuvant chemotherapy or hormonal therapy

2) Presence of medical disease such as uncontrolled asthma, renal dysfunction (S Creatinine and/or creatinine clearance beyond normal limits, deranged LFTs SGOT, SGPT > 3 time ULN)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the gene expression profiling (transcriptomic analysis) changes in breast tissue associated with peri-operative vaporization of herbal cannabis in patient undergoing primary surgery for breast cancer.Timepoint: After enrollment one 10 min before drug administration, Before administration of anesthesia at start of surgery, at the middle of the surgery procedure and at end of surgery just before wound closure.

Secondary Outcome Measures

Name	Time	Method
1.To assess the safety of cannabinoid vaporization in breast cancer patients in the peri-operative periodTimepoint: From first dose of study intervention to post operative day 1, day2, day 3, day 14 and day 28;2.To document the pharmacokinetic distribution of Tetrahydrocannabinol (THC) and Cannabidiol (CBD) in the blood during surgery at specific time points as detailed in the protocol.Timepoint: 5 minutes prior of Drug administration, before and immediately after surgery on day 0, day 1, day 2, day 3 and day 14;3.Immunohistochemical analysis of the CB1/CB2 receptors and effect of peri-operative cannabis on their expression in breast cancerTimepoint: After surgery