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
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.
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.
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