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Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00020618
First Posted: February 27, 2004
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Pain Unspecified Adult Solid Tumor, Protocol Specific Drug: morphine sulfate Procedure: quality-of-life assessment Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2001
Study Completion Date: February 2004
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00020618


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Nathaniel Katz, MD Dana-Farber Cancer Institute
  More Information

ClinicalTrials.gov Identifier: NCT00020618     History of Changes
Other Study ID Numbers: DFCI-MOR-00-01
CDR0000068672 ( Registry Identifier: PDQ (Physician Data Query) )
ARADIGM-MOR-00-01
BWH-2000-P-001516
First Submitted: July 11, 2001
First Posted: February 27, 2004
Last Update Posted: July 18, 2013
Last Verified: February 2002

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
pain

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents