Red Morphine Drops for Symptomatic Treatment of Dyspnoea in Lung Cancer

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338481

Enrollment

Registered

2006-06-20

Start date

2006-04-30

Completion date

2011-02-28

Last updated

2011-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Lung Neoplasms

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.

Interventions

DRUGMorphine 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.

DRUGMorphine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Dyspnea on a VAS scale	1 hour

Secondary

Measure	Time frame
Respiratory rate, pulse rate, oxygen saturation	1 hour

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026