Break-1
Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain
Sponsor study identifier
observational
500
1 country
3
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 20, 2014
Actual (reported)February 21, 2014
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
number of patients who experience BTcP
one year
treatments used to treat BTcP
one year
pain intensity
4 weeks
time to pain relief of BTcP
4 weeks
initial dose of therapy (in morphine equivalents) for BTcP
4 weeks
effective dose for BTcP
4 weeks
Patients with advanced cancer and chronic pain being controlled with opiods.
Ospedale San Leonardo
Castellammare di Stabia, Italy
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Naples, Italy
S. Maria della Pietà
Nola, Italy
Arturo Cuomo, M.D.
NCI Naples, Division of Pain Therapy
Francesco Perrone, M.D., Ph.D.
NCI Naples, Clinical Trials Unit
First Submitted
February 20, 2014
First Posted
February 21, 2014
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2023
Estimated (date passed)An Ancillary Pilot Trial Using Whole Genome Sequencing In Patients With Advance Refractory Cancer
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 24, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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