NCT01669499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2012

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

4.3 years

First QC Date

August 16, 2012

Last Update Submit

November 15, 2016

Conditions

Bone Metastases

Keywords

Bone metastases, radiotherapy, dexamethasone, pain flare

Outcome Measures

Primary Outcomes (1)

  • The occurrence of a pain flare.

    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).

    Within 2 weeks after irradiation

Secondary Outcomes (3)

  • Pain scores

    Days 1-14 and 28

  • Quality of life

    Days 7, 14 and 28

  • Side effects

    Day 1-14

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo on day 0-3

Drug: Placebo

Dexamethasone acetate day 0

ACTIVE COMPARATOR

8 mg dexamethasone on day 0

Drug: Dexamethasone acetateDrug: Placebo

Dexamethasone acetate day 0-3

ACTIVE COMPARATOR

8 mg dexamethasone on day 0-3

Drug: Dexamethasone acetate

Interventions

Dexamethasone acetateDRUG
Dexamethasone acetate day 0Dexamethasone acetate day 0-3
PlaceboDRUG
Dexamethasone acetate day 0Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University Medical Centre

Leiden, South Holland, 2333 ZA, Netherlands

Location

University Medical Center Utrecht

Utrecht, Utrecht, 3485 CX, Netherlands

Location

Related Publications (1)

  • Westhoff PG, de Graeff A, Geerling JI, Reyners AK, van der Linden YM. Dexamethasone for the prevention of a pain flare after palliative radiotherapy for painful bone metastases: a multicenter double-blind placebo-controlled randomized trial. BMC Cancer. 2014 May 20;14:347. doi: 10.1186/1471-2407-14-347.

    PMID: 24885354DERIVED

MeSH Terms

Interventions

dexamethasone acetate

Study Officials

  • Alexander de Graeff, MD, PhD

    Medical Oncologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 21, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

NL(2)