Treatment for Chronic Pain in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2009-02-10
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain.

PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Treatments: Dextromethorphan; Morphine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven advanced cancer with chronic pain

• Cancer pain requiring strong opioids having an average pain score of less than 6/10 on the visual analog scale within last 24 hours

• Pain managed by a stable maintenance dose of MS-Contin formulation of morphine for at least 2 days with no more than 2 breakthrough immediate release morphine doses per 24 hours

• Pain that is expected to be controlled by a stable and adequate total daily dose of sustained release morphine for the first 7 days of the study

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• Not specified

Life expectancy:

• At least 2 months

Hematopoietic:

• Not specified

Hepatic:

• SGOT or SGPT no greater than 3 times upper limit of normal (ULN)

• No liver disease

Renal:

• Creatinine no greater than 2 times ULN

• No kidney failure

Pulmonary:

• No clinically significant respiratory depression

• No severe obstructive airway disease

Other:

• Fluent in English or French

• No known hypersensitivity or allergy to study medications or components or other multiple drug allergies

• Normal cognition defined by the Folstein Mini-Mental State Questionnaire (at least 24/30 correct)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 14 days since prior chemotherapy

Endocrine therapy:

• Concurrent steroids allowed

Radiotherapy:

• At least 14 days since prior analgesic radiotherapy

Surgery:

• Not specified

Other:

• At least 3 months since prior investigational agents

• At least 1 month since prior clinical study

• No concurrent analgesics other than morphine

• No other concurrent medications containing dextromethorphan

• Concurrent antidepressant medication allowed

• Concurrent nonsteroidal antiinflammatory drugs allowed

• At least 14 days since prior monoamine oxidase (MAO) inhibitors

• No concurrent MAO inhibitors