A Phase II Study of Dexamethasone in the Prophylaxis of Radiation-Induced Pain Flare

Official Title

Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiation Therapy for Bone Metastases - A Phase II Study.

Summary:

The purpose of this study is to find out whether it is better to receive a drug called dexamethasone to prevent pain flare as a result of radiation therapy. This research is being done to test if dexamethasone can prevent the pain flare from the radiation treatment.

Trial Description

Study Objectives:

• To examine the effectiveness in protection from radiation induced pain flare with prophylactic dexamethasone
• To examine the toxicity of dexamethasone
• To examine quality of life of patients
• To correlate the pain flare (or not) with the response at 6 weeks following the completion of radiation treatment

Primary Endpoint: Complete control of pain flare during radiation therapy and the following 5 days after the completion of radiation treatment. 

Secondary Endpoints:

• Complete control of pain flare from day 6-10 after the completion of radiation treatment
• Quality of life
• Toxicity