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Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain Clinical research trials and Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain. Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain clinical trial. Human subjects often obtain the finest healthcare possible for their Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain  Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
For Condition: Pain,unspecified adult solid tumor, protocol specific,Quality of Life
Status: Completed
Sponsor(s): Dana-Farber/Harvard Cancer Center ,
Synopsis: RATIONALE: Morphine that is inhaled may be more rapidly absorbed than morphine that is given by mouth. It is not yet known if inhaled morphine is more effective than morphine given by mouth in relieving breakthrough pain. PURPOSE: Randomized phase II trial to compare the effectiveness of inhaled morphine with that of morphine given by mouth in treating cancer patients who have breakthrough pain.
Details: OBJECTIVES: I. Compare the change in pain intensity during the 15 minutes immediately following aerosolized vs oral morphine sulfate in cancer patients with opioid-sensitive breakthrough pain. II. Compare preference for continued use of these regimens in these patients. III. Compare the pain relief in patients treated with these regimens. IV. Evaluate satisfaction of patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are randomized to 1 of 2 treatment arms. Patients undergo titration of aerosolized morphine sulfate over days 1-7 to determine the optimal baseline and breakthrough dosage. Arm I: Patients receive aerosolized morphine sulfate as needed for breakthrough pain, up to 4 inhalations every 15 minutes, on days 8-14. Patients crossover to oral morphine sulfate as needed for breakthrough pain on days 15-21. Arm II: Patients receive oral morphine sulfate as needed for breakthrough pain on days 8-14. Patients crossover to aerosolized morphine sulfate as needed for breakthrough pain, up to 4 inhalations every 15 minutes, on days 15-21. Patients may continue treatment with either oral or aerosolized morphine sulfate for an additional 60 days beginning on day 22. Quality of life is assessed weekly for 3 weeks. Patients complete a pain management satisfaction survey at the end of each therapy crossover week. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Opioid-sensitive breakthrough pain due to cancer; More than 1 episode daily; Oral opiate dose of no more than 100 mg of morphine - No known allergy to morphine or other opioids - No known CNS excitatory response to morphine or other opioids - No unstable persistent morbidity due to prior chemotherapy or radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Recovered from prior chemotherapy; No concurrent chemotherapy that would cause toxicity (e.g., emesis) - Endocrine therapy: Not specified - Radiotherapy: Recovered from prior radiotherapy; No concurrent radiotherapy that would cause toxicity (e.g., emesis) - Surgery: Not specified - Other: At least 30 days or 5 half-lives (whichever is longer) since prior investigational drug; No concurrent MAO inhibitors --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-3 - Life expectancy: More than 3 months - Hematopoietic: Not specified - Hepatic: Bilirubin less than 2.0 mg/dL; AST less than 82 U/L; ALT less than 72 U/L - Renal: Creatinine less than 1.5 mg/dL - Pulmonary: No significant history or recent exacerbation of bronchial asthma; No chronic obstructive pulmonary disease; No significant pulmonary pathology that would preclude study - Other: No history of substance abuse, including alcohol, within the past 2 months; No other condition that would preclude study; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NathanielKatz, Study Chair, Dana-Farber/Harvard Cancer Center
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000068672; ARADIGM-MOR-00-01,DFCI-MOR-00-01,BWH-2000-P-001516
Study Start Date: March 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020618
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Nonpharmacologic Analgesia for Invasive Procedures
2. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
3. Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer
4. Prialt (ziconotide) In Severe Chronic Pain
5. Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
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Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
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