Clinical effect of vaporized CAnnabinoids on BReast cancer genetic EXpression patterns in the peri-operative period - CABREX Study

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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)

•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

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