Dexamethasone for Pain Flare After Radiotherapy of Painful Bone metastasesZonMW 11510009

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by UMC Utrecht
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014