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Treatment for Chronic Pain in Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003687
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief 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.


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

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Chronic Myeloid Leukemia Multiple Myeloma Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Polycythemia Vera Essential Thrombocythemia Chronic Myeloproliferative Disorders Myelodysplastic Syndromes Lymphosarcoma B-cell Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Diffuse Large B-Cell Lymphoma Primary Myelofibrosis Adult T-cell Leukemia/lymphoma Hodgkin Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Waldenstrom Macroglobulinemia Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Primary Central Nervous System Lymphoma AL Amyloidosis Monoclonal Gammopathy of Undetermined Significance Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Hairy Cell Leukemia Small Intestine Cancer Burkitt Lymphoma Mycosis Fungoides Sezary Syndrome Anaplastic Large Cell Lymphoma Cutaneous T-cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Plasmacytoma Leukemia, T-cell, Chronic Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Chronic Neutrophilic Leukemia Aggressive NK Cell Leukemia T-cell Large Granular Lymphocyte Leukemia





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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
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
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Study Chair: Eduardo Bruera, MD M.D. Anderson Cancer Center
Publications of Results:
MacDonald S, Dudgeon DJ, Bruera E, et al.: 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. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1521, 2002.

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
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
Additional relevant MeSH terms:
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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