Red Morphine Drops for Symptomatic Treatment of Dyspnoea in Lung Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dyspnea, Lung Neoplasms

Intervention / Treatment
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* Drug: Morphine p.o.
* Drug: Morphine s.c.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Morphine p.o.<br>* 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.<br>|
| Active Comparator: 2<br> | Drug: Morphine s.c.<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea on a VAS scale |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate, pulse rate, oxygen saturation |  | 1 hour |