Phase 2 pilot study to test the efficacy of Ayurvedic oral cannabis preparation in the peri-operative period in oral cavity squamous cell cancer. - Nil

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•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

•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

发起方