Clinical trial · Interventional
Dexamethasone for the Prophylaxis of Pain Flare Study
Dexamethasone for the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Radiation treatment is often recommended as a safe and quick treatment that gives most people good relief from bone pain within a couple of weeks. However, some people can experience a short episode of increased pain (called a 'flare') a day or two after radiation treatment, that lasts about a day. The purpose of this sturdy is to find out if a medication called dexamethasone can help prevent pain flare as a result of radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dexamethasone
- description
- 8mg Dexamethasone PO on days 0 (prior to radiation treatment), and days 1, 2, and 3 following radiation treatment.
- interventionNames
- Drug: dexamethasone
Primary outcomes (1)
- measure
- Complete control of pain flare on days 1-5 after the completion of radiation treatment.
- timeFrame
- Days 1-5
Secondary outcomes (3)
- measure
- Complete control of pain flare from Day 6-10 after the completion of radiation treatment.
- timeFrame
- Days 6-10
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented bone metastases by radiological imaging * Patients at least 18 years of age * Written consent * KPS ≥ 40 * Baseline worst pain at the planned radiated bony metastatic site ≥ 2 * Patient able to inform the pain score at the planned radiated bony metastatic site Exclusion Criteria: * Concurrent use of any corticosteroid medication other than topical or inhaled preparations * Medical contraindications to corticosteroids such as diabetes mellitus, uncontrolled hypertension or active peptic ulcer * Pathological fracture of the irradiated extremity * Spinal cord compression * Language barrier * Immediate change in regular analgesic medication. If the oncologist thinks the patient is not receiving adequate analgesic, we recommend the oncologist to increase the analgesic first to stabilize ot lessen the pain before recruiting the patient to this study
References
Publications (0)
Data not yet available