Chow, E., Meyer, R.M., Ding, K., Nabid, A., Chabot, P., Wong, P., . . . Wong, R.K. (2015). Dexamethasone in the prophylaxis of radiation-induced pain flare after palliative radiotherapy for bone metastases: A double-blind, randomised placebo-controlled, phase 3 trial. Lancet Oncology, 16, 1463–1472. 

To compare the efficacy of dexamethasone to placebo for prevention of pain flare after palliative radiotherapy

Patients were randomized to receive either 8 mg dexamethasone or placebo at least one hour before the start of radiotherapy and then daily while receiving radiotherapy. Patients completed study assessments at baseline, day 10, and day 42 after radiation treatment.

• N = 298   
• MEDIAN AGE = 69 years
• AGE RANGE = 58–77 years
• MALES: 57%, FEMALES: 43%
• CURRENT TREATMENT: Radiation
• KEY DISEASE CHARACTERISTICS: Multiple tumor types—breast, prostate, and lung were predominant. Single dose of 8 Gy was used to target volumes planned.
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 50% had worst pain at baseline between 7–10 on the numeric scale.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Canada

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care, palliative care 

• Double-blind, placebo-controlled

• Brief Pain Inventory (BPI)
• Daily pain diary with numeric scale
• EORTC QLQ-C15-PAL for palliative, EORTC QLQ-C30 for quality of life, and EORTC QLQ-BM22 for bone metastases
• Dexamethasone Symptom Questionnaire (DSQ)

Median follow-up ranged from 1-39 months. Ninety-two patients experienced pain flare on days 0–10, 26% in the dexamethasone group and 35% in the placebo group (p = 0.05). The incidence of pain flare was 11.8% lower in the dexamethasone group (p = 0.01). No significant differences were noted between groups in overall pain reduction from radiotherapy or analgesic intake. Three patients on dexamethasone stopped the study medication due to hyperglycemic events. Two of these had preexisting diabetes.

Provision of 8 mg dexamethasone prior to and daily during palliative radiation therapy for bone metastases was effective in the prevention of radiation-associated pain flare compared to placebo.

• High variability in follow-up measurement time frames

This study showed that administration of dexamethasone during palliative radiation therapy for bone metastases was effective in preventing bone flare pain. A few patients developed hyperglycemic episodes while on dexamethasone, so nurses need to be aware of this potential, particularly in patients with preexisting diabetes. The purpose of palliative radiation is pain reduction, so it also makes sense to intervene to prevent pain flare that can occur from that treatment. Further research is warranted to compare prophylactic versus treatment of bone flare pain, and potential efficacy of other adjuvant medications.