drugset / Trial / NCT01669499

Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009

NCT01669499 ↗

RandomizedParallel-groupTriple-blindSupportive care

Summary

Cancer patients with pain due to bone metastases are often treated with external irradiation in order to reduce pain. However, patients may experience a temporary increase of pain shortly after irradiation, a so-called pain flare. This study investigates whether a short course of a drug called dexamethasone may prevent the occurrence of a pain flare. Patients, who are irradiated for painful bone metastases are randomized into three groups. Group 1 receives placebo during four days, group 2 receives dexamethasone on the day of the irradiation and placebo during three days, and group 3 receives dexamethasone during four days. All patients complete a questionnaire on pain, side-effects of treatment and quality of life during 14 days and after four weeks. This study will define whether dexamethasone decreases the occurrence of a pain flare after irradiation for painful bone metastases, and, if so, whether four days of treatment with dexamethasone is better dan one day of treatment.

Timeline

Start
2012-01
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 8 mg Oral

Indications