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
18 Years
N/A
Both
Pain, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
week.
PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Principal Investigator
Nathaniel Katz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068672
NCT ID:
NCT00020618
Start Date:
March 2001
Completion Date:
Related Keywords:
- Pain
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- pain
Name | Location |
|---|---|
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
