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Table 1 Full inclusion and exclusion criteria

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

Inclusion

Patients of 18 years or older

 

Uncomplicated painful bone metastases

 

Primary malignancy is a solid tumor

 

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

Patients with haematological malignancy

 

Multiple sites to be irradiated

 

Patients who have been treated before with palliative radiotherapy for painful bone metastases to the same bony localisation

 

Current use of steroids (dexamethasone, prednisolone or other), use up to less than a week before randomization or expected use within 2 weeks after start of radiotherapy (e.g., as part of anti-emetic regimen for chemotherapy)

 

Contraindications for the use of dexamethasone (to be judged by the radiation-oncologist)

 

Long-term schedule radiotherapy (>6 fractions)

 

Life expectancy shorter than 8 weeks

 

Karnofsky performance score of 40 or less