Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

Inclusion Criteria: * Have a histologically or cytologically proven malignancy. All non-hematologic malignant tumours of any histology are eligible. * Be 18 years of age or older at the time of randomization. * Have bone metastasis(es) corresponding to the clinically painful area(s) documented by radiological imaging within six months prior to randomization. * Karnofsky Performance Status (KPS) must be ≥ 40 at the time of the baseline evaluation (within seven days prior to randomization). As it is difficult to obtain complete data from inpatients on a daily basis, they should not be randomized to this study. * Is planned to receive palliative radiotherapy to one or two bony metastasis(es) with the treatment given as 8 Gy in a single fraction to all sites to be followed for the study. Although a maximum of two sites can be treated and followed for the study, patients with more than two skeletal metastases are eligible. At the time of delivery of study radiotherapy, only the site(s) being followed for the study may be treated. * Is able to provide the worst pain score at the bony metastatic site(s) planned for palliative radiotherapy. * Has a baseline worst pain score ≥ 2 on a scale of 0-10 at all the bony metastatic site(s) planned for palliative radiotherapy as part of this study within 7 days prior to randomization. If two painful sites will be followed for the study, this requirement must be met on the same day for both sites. * Is able and willing to fill out the daily di…