A double blind placebo controlled randomized trial on oral cannabis for chronic cancer pain relief.

Tata Memorial Centre Mumbai0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年8月2日

试验速览

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•1.Adult patients with advanced cancer and only on palliation or supportive care with moderate cancer pain (NRS: 3-6) referred for the first time to the pain clinic
•2.Patients with chronic cancer pain without painful bony metastases
•3.Patients with cancer pain with stable brain metastases
•4.Literate (able to read, write and speak in either Hindi, English, Marathi)

•1.Cancer patients less than 18 years of age
•2.Elderly patients.70 years of age
•3.Unable to follow up or patients returning to the pain clinic for a review
•4.Painful bone metastases receiving radiotherapy
•5.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)
•6.Cognitive impaired patient
•7.Known psychiatric illness- Personal history of psychiatric disease or Significant family history of psychiatric disease
•8.Refusal of consent
•9.History of substance abuse (including cannabis-related products) or alcohol abuse
•10.Patients currently (within last 14 days before consenting) on other CNS depressants such as alcohol, barbiturates, benozodiazapines (like diazepam, alprazolam etc)
•11.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.
•12.Any other illness or abnormal laboratory investigations which the investigator considers as making the patients ineligible for the study

发起方

Tata Memorial Centre Mumbai