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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain, Unspecified Adult Solid Tumor, Protocol Specific

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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 HospitalBoston, Massachusetts  02115