Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Patients of 18 years or older

• Uncomplicated painful bone metastases

• Primary malignancy is a solid tumour • Pain intensity on a numeric rating scale of 2-8

• No immediately expected change in the analgesic regimen.

• Indication for single or short course radiotherapy

• Able to fill out Dutch questionnaires

• Able to follow instructions

• Informed consent provided

Exclusion Criteria:

• Patients with hematological malignancy

• Multliple sites to be irradiated

• Patients who have been treated before with palliative radiotherapy for painful bone metastases

• Current use of steroids (dexamethasone, prednisolone or other), or use up to less than a week before randomization

• Long-term schedule radiotherapy (>6 fractions)

• Life expectancy shorter than 8 weeks

• Karnofsky Performance Score of 40 or less