An Open Label, Randomized, Multicenter, Crossover, Phase II Study to Compare Pain Relief Following Morphine Administration Via AERxPMS vs Orally in Cancer Patients Experiencing Opioid-Sensitive Breakthrough Pain
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.
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
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Primary Purpose: Supportive Care
Nathaniel Katz, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Brigham and Women's Hospital||Boston, Massachusetts 02115|