"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Sankt Lukas Hospice
ClinicalTrials.gov Identifier:
NCT00338481
First received: June 16, 2006
Last updated: July 26, 2011
Last verified: February 2011

June 16, 2006
July 26, 2011
April 2006
February 2011   (final data collection date for primary outcome measure)
Dyspnea on a VAS scale [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Dyspnea on a VAS-scale 0-5-10-15-20-30-60 min after morphine administration.
Complete list of historical versions of study NCT00338481 on ClinicalTrials.gov Archive Site
Respiratory rate, pulse rate, oxygen saturation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Oxygen saturation and respiratory frequency 0-5-10-15-20-30-60 min after morphine administration.
Not Provided
Not Provided
 
"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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Dyspnea
  • Lung Neoplasms
  • 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
  • Active Comparator: 1
    Intervention: Drug: Morphine p.o.
  • Active Comparator: 2
    Intervention: Drug: Morphine s.c.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00338481
2005-060-version1a
Yes
Torben Krantz, Sankt Lukas Hospice
Sankt Lukas Hospice
Not Provided
Principal Investigator: Torben Krantz, Physician Sankt Lukas Hospice
Sankt Lukas Hospice
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP