CompletedPhase 3

Treatment for Chronic Pain in Patients With Advanced Cancer

Canada87 participantsStarted 1998-06-11

Plain-language 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.

Who can participate

Age range

16 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 spec…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00003687

SponsorNCIC Clinical Trials Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2001-09-26

View on ClinicalTrials.gov More Chronic Myeloproliferative Disorders trials