Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009
This study is currently recruiting participants.
Verified August 2012 by UMC Utrecht
Sponsor:
UMC Utrecht
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
A. de Graeff, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01669499
First received: August 16, 2012
Last updated: August 20, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Metastases |
Drug: Dexamethasone acetate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Dexamethasone for the Prevention of a Pain Flare After Palliative Radiotherapy for Painful Bone Metastases: a Multi-center Double-blind Placebo-controlled Randomized Study |
Resource links provided by NLM:
Further study details as provided by UMC Utrecht:
Primary Outcome Measures:
- The occurrence of a pain flare. [ Time Frame: Within 2 weeks after irradiation ] [ Designated as safety issue: No ]A pain flare is defined by a two-point increase after radiotherapy of the worst pain score on Pain flare is defined as an 11-point scale of 0 (no pain) to 10 (worst imaginable pain) compared to baseline without a decrease in analgesic intake, or a 25% increase in analgesic intake without decrease in worst pain score (according to international bone metastases consensus guidelines) (Chow 2007).
Secondary Outcome Measures:
- Pain scores [ Time Frame: Days 1-14 and 28 ] [ Designated as safety issue: No ]Pain scores as measured by BPI
- Quality of life [ Time Frame: Days 7, 14 and 28 ] [ Designated as safety issue: No ]As measured by the quality of life scale of the EORTC PAL15
- Side effects [ Time Frame: Day 1-14 ] [ Designated as safety issue: Yes ]As measured by questionnaire
| Estimated Enrollment: | 411 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo on day 0-3
|
Drug: Placebo |
|
Active Comparator: Dexamethasone acetate day 0
8 mg dexamethasone on day 0
|
Drug: Dexamethasone acetate Drug: Placebo |
|
Active Comparator: Dexamethasone acetate day 0-3
8 mg dexamethasone on day 0-3
|
Drug: Dexamethasone acetate |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669499
Contacts
| Contact: Alexander de Graeff, MD, PhD | 31887556265 | a.degraeff@umcutrecht.nl |
| Contact: Yvette M van der Linden, MD, PhD | 31715269111 | Y.M.van_der_linden@lumc.nl |
Locations
| Netherlands | |
| Leiden University Medical Centre | Recruiting |
| Leiden, Zuid-Holland, Netherlands, 2333 ZA | |
| Principal Investigator: Yvette M van der Linden, MD, PhD | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3485 CX | |
| Principal Investigator: Alexander de Graeff, MD, PhD | |
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Alexander de Graeff, MD, PhD | Medical Oncologist |
More Information
No publications provided
| Responsible Party: | A. de Graeff, Associate professor, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01669499 History of Changes |
| Other Study ID Numbers: | ZonMW 11510009 |
| Study First Received: | August 16, 2012 |
| Last Updated: | August 20, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by UMC Utrecht:
|
Bone metastases, radiotherapy, dexamethasone, pain flare |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013