Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009 (NCT01669499) | Clinical Trial Compass
CompletedPhase 3
Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009
Netherlands411 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.