Bone metastases
Conditions
Interventions
Trade Name: dexamethasone
Product Name: dexamethasone
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
ZonMw
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effectiveness of dexamethasone for the prevention of a pain flare after radiotherapy for painful bone metastases;Secondary Objective: To determine the optimal dosing schedule for dexamethasone for the prevention of a pain flare after radiotherapy for painful bone metastases. To determine whehter a pain flare predicts for pain response after radiotherapy.;Primary end point(s): The primary outcome measure of the study is the occurrence of a pain flare as defined by a two-point increase after radiotherapy of the worst pain score on an 11-point scale of 0 (no pain) to 10 (worst imaginable pain) compared to baseline without a decrease in analgesic intake, or a 25% increase in analgesic intake without decrease in worst pain score (according to international bone metastases consensus guidelines) (Chow 2002). Pain flare will be distinguished from progression of pain by requiring the worst pain score and analgesic intake to return to baseline levels after increase/flare (within 14 days of follow up). | — |
Countries
Netherlands
Outcome results
None listed