To study the effect of cannabis capsules (medical Ganja) taken orally as compare to placebo( no active treatment) for pain relief in chronic cancer.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/07/044046

Enrollment

Registered

2022-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site Health Condition 2: R52- Pain, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Reduction in pain severityTimepoint: 4 weeks after randomisation	—

Secondary

Measure	Time frame
Adverse effectsTimepoint: till 4 weeks after randomisation;Effect on quality of lifeTimepoint: 4 weeks after randomisation ;Escalating dose-responseTimepoint: 4 weeks after randomisation;Withdrawal from the studyTimepoint: till 4 weeks after randomisation	—

Countries

India

Contacts

Public ContactDr Aparna Chatterjee

Tata Memorial Hospital, Parel, Mumbai

aparnasanjay@hotmail.com022024177051

Outcome results