Trial | NCT00338481  Report issue

Title

"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    morphine ...

  • Study Participants

    20
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.
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.
Study Started
Apr 30
2006
Primary Completion
Feb 28
2011
Study Completion
Feb 28
2011
Last Update
Jul 27
2011
Estimate

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.

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

1 Active Comparator

2 Active Comparator

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
No Results Posted