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

Sponsored by:	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	Phase IV

MedlinePlus related topics: Breathing Problems Cancer Hospice Care Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Further study details as provided by Sankt Lukas Hospice:

Primary Outcome Measures:

Dyspnea on a VAS-scale 0-5-10-15-20-30-60 min after morphine administration.

Secondary Outcome Measures:

Oxygen saturation and respiratory frequency 0-5-10-15-20-30-60 min after morphine administration.

Estimated Enrollment:	20
Study Start Date:	April 2006
Estimated Study Completion Date:	January 2007

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

Contacts

Contact: Helle Gamborg, Nurse	+4539455136	jmuller@pc.dk
Contact: Torben Krantz, Physician	+4539455132	torbenkrantz@dadlnet.dk

Locations

Denmark, Hellerup
Sankt Lukas Hospice	Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Torben Krantz, Physician +4539455132 torbenkrantz@dadlnet.dk

Sponsors and Collaborators

Sankt Lukas Hospice

Investigators

Principal Investigator:

Torben Krantz, Physician

Sankt Lukas Hospice

More Information

Study ID Numbers:	2005-060-version1a
Study First Received:	June 16, 2006
Last Updated:	June 16, 2006
ClinicalTrials.gov Identifier:	NCT00338481
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Thoracic Neoplasms
Morphine
Signs and Symptoms
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Dyspnea

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009