"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer - Full Text View

Sponsor:	Sankt Lukas Hospice
Information provided by:	Sankt Lukas Hospice
ClinicalTrials.gov Identifier:	NCT00338481

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 IV

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:

MedlinePlus related topics: Breathing Problems Cancer Hospice Care Lung Cancer

U.S. FDA Resources

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

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:

Neoplasms
Dyspnea
Lung Neoplasms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases

Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012