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"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
  Purpose

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 Intervention Phase
Dyspnea
Lung Neoplasms
Drug: Morphine p.o.
Drug: Morphine s.c.
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sankt Lukas Hospice:

Primary Outcome Measures:
  • Dyspnea on a VAS scale [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory rate, pulse rate, oxygen saturation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338481

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

No publications provided

Responsible Party: Torben Krantz, Sankt Lukas Hospice
ClinicalTrials.gov Identifier: NCT00338481     History of Changes
Other Study ID Numbers: 2005-060-version1a
Study First Received: June 16, 2006
Last Updated: July 26, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Dyspnea
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Signs and Symptoms
Signs and Symptoms, Respiratory
Thoracic Neoplasms
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014