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

Primary Purpose

Pain, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
morphine sulfate
quality-of-life assessment
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring unspecified adult solid tumor, protocol specific, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
July 17, 2013
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00020618
Brief Title
Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2002
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
morphine sulfate
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Katz, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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

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