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Cannabis Oil and Radiation Therapy for the Management of Pain

NCT03763851 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-12

No results posted yet for this study

Summary

In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.

Conditions

Interventions

RADIATION

Active PPP005

Group assigned to active PPP005 in the randomized placebo-controlled trial

RADIATION

Radiotherapy

Palliative RadioTherapy to the symptomatic site

Sponsors & Collaborators

  • Santé Cannabis

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Tetra Bio-Pharma

    lead INDUSTRY

Principal Investigators

  • Tamim Niazi, MD · Jewish General Hospital, McGill University

  • Jean Zigby, MD · Jewish General Hospital, McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-14
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763851 on ClinicalTrials.gov