"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study|
- Dyspnea on a VAS scale [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
- Respiratory rate, pulse rate, oxygen saturation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Drug: Morphine p.o.
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.
|Active Comparator: 2||
Drug: Morphine s.c.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338481
|Sankt Lukas Hospice|
|Copenhagen, Hellerup, Denmark, 2900|
|Principal Investigator:||Torben Krantz, Physician||Sankt Lukas Hospice|