Completed

NCT Number: NCT00003687

Treatment for Chronic Pain in Patients With Advanced Cancer

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.

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Key information

Conditions

Chronic Myeloproliferative Disorders Amyloidosis Blast Crisis Blood Coagulation Disorders Blood Platelet Disorders Blood Protein Disorders Bone Marrow Diseases Bone Marrow Neoplasms Burkitt Lymphoma Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Hypergammaglobulinemia Immune System Diseases Immunoblastic Lymphadenopathy Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Leukemia, Prolymphocytic Leukemia, T-Cell Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Metabolic Diseases Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Neoplastic Processes Neurologic Manifestations Nutritional and Metabolic Diseases Pain Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Polycythemia Vera Precancerous Conditions Precancerous/Nonmalignant Condition Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Primary Myelofibrosis Proteostasis Deficiencies Sezary Syndrome Signs and Symptoms Small Intestine Cancer Thrombocythemia, Essential Thrombocytosis Tumor Virus Infections Unspecified Adult Solid Tumor, Protocol Specific Vascular Diseases Virus Diseases Waldenstrom Macroglobulinemia

Age range

16 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dextromethorphan hydrobromide

Drug

Morphine sulfate

Drug

Sponsors and collaborators

Lead sponsor

NCIC Clinical Trials Group

Network

Registry information

Official study 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

Important dates

Study start: 1998
Primary completion: 2001
Study completion: 2009
First posted: Jan 27, 2003
Registry last updated: Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed