"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
Primary Purpose
Dyspnea, Lung Neoplasms
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Morphine p.o.
Morphine s.c.
Sponsored by
About this trial
This is an interventional treatment trial for Dyspnea
Eligibility Criteria
Inclusion Criteria: Primary lung cancer or lung metastases and Moderate to severe dyspnea at rest (VAS equal to or more than 30) Exclusion Criteria: Causal treatment of dyspnea possible and indicated Not receiving opioids on a regular basis Methadone treatment Intolerance to morphine Without understanding of patient information Depressed consciousness Oxygen treatment, if changed with-in 20 min before start Short-acting opioids with-in 4 h before start Inhalation therapy for bronchodilation with-in 20 min before start
Sites / Locations
- Sankt Lukas Hospice
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Dyspnea on a VAS scale
Secondary Outcome Measures
Respiratory rate, pulse rate, oxygen saturation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00338481
Brief Title
"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
Official Title
"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sankt Lukas Hospice
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.
Detailed Description
Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time.
Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Lung Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Morphine p.o.
Intervention Description
Morphine p.o. in "red morphine drops" calculated as 1/12 of the 24 hours opioid consumption converted to morphine p.o., max. 24 mg morphine p.o.and isotonic sodium chloride s.c.
Intervention Type
Drug
Intervention Name(s)
Morphine s.c.
Intervention Description
False "red morphine drops" without morphine p.o. and 60% of 1/12 of the 24 hours opioid consumption converted to morphine p.o. but given s.c., max. 14,4 mg
Primary Outcome Measure Information:
Title
Dyspnea on a VAS scale
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Respiratory rate, pulse rate, oxygen saturation
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary lung cancer or lung metastases and
Moderate to severe dyspnea at rest (VAS equal to or more than 30)
Exclusion Criteria:
Causal treatment of dyspnea possible and indicated
Not receiving opioids on a regular basis
Methadone treatment
Intolerance to morphine
Without understanding of patient information
Depressed consciousness
Oxygen treatment, if changed with-in 20 min before start
Short-acting opioids with-in 4 h before start
Inhalation therapy for bronchodilation with-in 20 min before start
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben Krantz, Physician
Organizational Affiliation
Sankt Lukas Hospice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sankt Lukas Hospice
City
Copenhagen
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
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"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
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