"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
Information source: Sankt Lukas Hospice
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dyspnea; Lung Neoplasms
Intervention: morphine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sankt Lukas Hospice Official(s) and/or principal investigator(s):
Torben Krantz, Physician, Principal Investigator, Affiliation: Sankt Lukas Hospice
Overall contact:
Helle Gamborg, Nurse, Phone: +4539455136, Email: jmuller@pc.dk
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study
Primary outcome: Dyspnea on a VAS-scale 0-5-10-15-20-30-60 min after morphine administration.
Secondary outcome: Oxygen saturation and respiratory frequency 0-5-10-15-20-30-60 min after morphine administration.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Helle Gamborg, Nurse, Phone: +4539455136, Email: jmuller@pc.dk
Sankt Lukas Hospice, Copenhagen, Hellerup 2900, Denmark; Recruiting
Torben Krantz, Physician, Phone: +4539455132, Email: torbenkrantz@dadlnet.dk
Additional Information
Starting date: April 2006
Ending date: January 2007
Last updated: June 16, 2006
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