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Treatment for Chronic Pain in Patients With Advanced Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Treatment for Chronic Pain in Patients With Advanced Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Treatment for Chronic Pain in Patients With Advanced Cancer Clinical research trials and Treatment for Chronic Pain in Patients With Advanced Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Treatment for Chronic Pain in Patients With Advanced Cancer. Treatment for Chronic Pain in Patients With Advanced Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Treatment for Chronic Pain in Patients With Advanced Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Treatment for Chronic Pain in Patients With Advanced Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment for Chronic Pain in Patients With Advanced Cancer  Treatment for Chronic Pain in Patients With Advanced Cancer
Treatment for Chronic Pain in Patients With Advanced Cancer
For Condition: Lymphoid Cancer,Pain,Hodgkin's Disease,AIDS-Related Lymphoma,Digestive System Cancer,Non-Hodgkin's Lymphoma,Leukemia
Status: Completed
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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 double blinded phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating patients with chronic pain from advanced cancer.
Details: 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. PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EduardoBruera, Study Chair, M.D. Anderson Cancer Center
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Additional Information:
Study ID Numbers: CDR0000066789; CAN-NCIC-SC17
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003687
Other Digestive System Cancer Studies:
1. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
2. A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas
3. Donor Th2 Cells to Prevent Graft-Versus-Host Disease in Bone Marrow Transplants
4. Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
5. Treatment for Chronic Pain in Patients With Advanced Cancer
Related Studies:
Other Digestive System Cancer Clinical Trials
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Other St. Johns Clinical Trials
Treatment for Chronic Pain in Patients With Advanced Cancer
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