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

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ClinicalTrials.gov Identifier: NCT00338481
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
Sankt Lukas Hospice

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.

Condition or disease Intervention/treatment Phase
Dyspnea Lung Neoplasms Drug: Morphine p.o. Drug: Morphine s.c. Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : April 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Dyspnea on a VAS scale [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Respiratory rate, pulse rate, oxygen saturation [ Time Frame: 1 hour ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338481


Locations
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Denmark
Sankt Lukas Hospice
Copenhagen, Hellerup, Denmark, 2900
Sponsors and Collaborators
Sankt Lukas Hospice
Investigators
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Principal Investigator: Torben Krantz, Physician Sankt Lukas Hospice

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Responsible Party: Torben Krantz, Sankt Lukas Hospice
ClinicalTrials.gov Identifier: NCT00338481     History of Changes
Other Study ID Numbers: 2005-060-version1a
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Lung Neoplasms
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents