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

NCT ID: NCT00338481

Last Updated: 2011-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-02-28

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.

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.

Conditions

Dyspnea; Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Morphine p.o.

Intervention Type: DRUG

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.

2

Group Type: ACTIVE_COMPARATOR

Morphine s.c.

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sankt Lukas Hospice

OTHER

Sponsor Role: lead

Responsible Party

Sankt Lukas Hospice

Principal Investigators

Torben Krantz, Physician

Role: PRINCIPAL_INVESTIGATOR

Sankt Lukas Hospice

Locations

Sankt Lukas Hospice

Copenhagen, Hellerup, Denmark

Countries

Denmark

Other Identifiers

2005-060-version1a

Identifier Type: -

Identifier Source: org_study_id