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

Phase 3

Completed

Conditions: Bone metastases
10040778

Registration Number: NL-OMON44067

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 294

Inclusion Criteria

Patients with uncomplicated painful bone metastases, treated with 1-6 fractions of palliative radiotherapy
Pain intensity on a numeric rating scale of 2-8
Able to complete Dutch questionnaire

Exclusion Criteria

Patients with hematological malignancies
Multiple sites to be irradiated
Previous radiotherapy for painful bone metastases
Current use of steroids or expected use within 2 weeks after radiotherapy
Life expectancy <8 weeks

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure of the study is the occurrence of a pain flare as<br /><br>defined by a two-point increase after radiotherapy of the worst pain score on<br /><br>an 11-point scale of 0 (no pain) to 10 (worst imaginable pain) compared to<br /><br>baseline without a decrease in analgesic intake, or a 25% increase in analgesic<br /><br>intake without decrease in worst pain score (according to international bone<br /><br>metastases consensus guidelines) (Chow 2007). Pain flare will be distinguished<br /><br>from progression of pain by requiring the worst pain score and analgesic intake<br /><br>to return to baseline levels after increase/flare (within 14 days of follow<br /><br>up).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br>* pain scores (BPI) on days 1-14 and on day 28<br /><br>* pain scales and quality of life (EORTC QLQ-BM22 and EORTC QLQ-PAL15) on days<br /><br>7, 14 and 28<br /><br>* side-effects of placebo and dexamethasone</p><br>