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Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases

NCT01248585 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2023-08-28

Study results available
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Summary

This research is being done because is is not known if dexamethasone can prevent pain flare (their pain temporarily gets worse before it gets better) caused by the radiation used to treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied in a few people and seems promising, but it is not clear if it can decrease the pain or prevent the pain flare before it happens.

Conditions

Interventions

DRUG

Dexamethasone

2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days

DRUG

Placebo

2 placebo tablets taken once daily for 5 days

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Edward LW Chow · Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON

  • Carlo De Angelis · Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON

  • Alysa Fairchild · Cross Cancer Institute, Edmonton AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-30
Primary Completion
2015-05-25
Completion
2015-11-27

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248585 on ClinicalTrials.gov