Treatment for Chronic Pain in Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT00003687 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 3, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Pain Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Drug: dextromethorphan hydrobromide Drug: morphine sulfate | Phase 3 |
OBJECTIVES:
- Compare the analgesic efficacy of two formulations of morphine (Statex SR versus MS-Contin) in patients requiring morphine for the treatment of chronic cancer pain.
- Compare the effect of these 2 formulations of morphine on the total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects experienced in the two treatment groups.
- Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups (phase B).
- Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects on the two treatment groups (phase B).
OUTLINE: This is a randomized, double-blind, parallel-group, multicenter study. Patients are stratified by stabilization dose (less than 120 mg/day vs greater than 120 mg/day of morphine) and institution in phase A, and neuropathic pain (yes vs no) in phase B.
- Phase A: Patients are randomized to receive oral morphine in one of two formulations (MS Contin or Statex SR) every 12 hours for 7 days.
- Phase B: Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours, and oral morphine tablets every 12 hours for 14 days.
- Phase C: All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days.
Patients complete a pain diary twice each day during treatment.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 87 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex SR for Chronic Cancer Pain Relief in Terminally Ill Patients |
Actual Study Start Date : | June 11, 1998 |
Actual Primary Completion Date : | September 26, 2001 |
Actual Study Completion Date : | February 10, 2009 |


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Ages Eligible for Study: | 16 Years to 120 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003687
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Newfoundland and Labrador | |
Newfoundland Cancer Treatment and Research Foundation | |
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
McGill University | |
Montreal, Quebec, Canada, H2W 1S6 |
Study Chair: | Eduardo Bruera, MD | M.D. Anderson Cancer Center |
Responsible Party: | NCIC Clinical Trials Group |
ClinicalTrials.gov Identifier: | NCT00003687 |
Other Study ID Numbers: |
SC17 CAN-NCIC-SC17 ( Other Identifier: PDQ ) CDR0000066789 ( Other Identifier: PDQ ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | April 3, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma monoclonal gammopathy of undetermined significance recurrent adult Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent adult acute myeloid leukemia |
recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia small intestine lymphoma unspecified adult solid tumor, protocol specific chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission polycythemia vera chronic idiopathic myelofibrosis |
Lymphoma Leukemia Multiple Myeloma Neoplasms, Plasma Cell Preleukemia Intestinal Neoplasms Precancerous Conditions Myelodysplastic Syndromes Myeloproliferative Disorders Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Disease Pathologic Processes Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |