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

Lung Neoplasms Clinical Trial

Official title:

"Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338481
• Other study ID #: 2005-060-version1a
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2006
• Last updated: July 26, 2011
• Start date: April 2006
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Sankt Lukas Hospice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea
• Lung Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
Denmark	Sankt Lukas Hospice	Copenhagen	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Sankt Lukas Hospice

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dyspnea on a VAS scale		1 hour	No
Secondary	Respiratory rate, pulse rate, oxygen saturation		1 hour	No