Morphine drops for rapid treatment of breathlessness in patients with cancer in incurable phase of the disease.

Phase 1

Conditions: Morphine drops for palliation of breathlessness in palliative cancer patients
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-004380-37-DK

Lead Sponsor: niversity Hospital Sjaelland, Roskilde,Palliative Unit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Cancerpatients in stable phase of the disease, performance status 0-2
Patients with breathlessness more than 1 on EORTC-QLQ-C15-PAL and 3 or more than 3 on questionaire ESAS
Hemoglobin more than 6 and no tranfusion needed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

Known allergy or intolerence against morphine or other opioids
Testpatients recieving chemo- or radiation therapy less than 7 days before inclusion
Impaired renal funktion (GFR<50)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to analyse how fast morphine drops in two wellknown formulates palliate breathlessness in cancer patients;Secondary Objective: To analyse changes in saturation, respiration frequens and pulse after 2 minute walk test and administration of test medicine.;Primary end point(s): Subjective palliation of breathlessness after 2 MWT(Minute Walk Test) and administration of test medicine;Timepoint(s) of evaluation of this end point: 5,10,15,20 and 30 minutes

Secondary Outcome Measures