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Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: a multicenter double-blind placebo-controlled randomized study - Dexamethasone for pain flare after radiotherapy

Conditions
Bone metastases
Registration Number
EUCTR2010-020174-42-NL
Lead Sponsor
ZonMw
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Uncomplicated painful bone metastases
Indication for single or short course of radiotherapy
Age >17 years
Solid tumor
Pain intensity on a numeric rating scale 2-8
No immediately expected changes in analgesic medication
Ability to complete Dutch questionnaire
informed consent

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Hematological malignancy
Multiple sites to be irradiated
Patinets who have been treated before with palliative radiotherapy for painful bone metastases
Current use of corticosteroids
Long-ternm schedule radiotherapy (>6 fractions)
Life expectancy ,8 weeks
Karnofsky Performance Statsu 40 or less

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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