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NCT02069067 Clinical Trial

Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated

Advanced Cancer Clinical Trial

— Break-1  

Official title:
Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02069067
Other study ID # Break-1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2011
Est. completion date December 2023

Study information
Verified date March 2023
Source National Cancer Institute, Naples
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 500
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of neoplasm in advanced stage - Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent - 1-6 episodes of BTcP within any of 3 days previous to registration into study - Signed Informed Consent Exclusion Criteria: ยท More than 6 episodes of BTcP within any of 3 days previous to registration into study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ospedale San Leonardo Castellammare di Stabia
Italy Istituto Nazionale dei Tumori , Unita Terapia Antalgica Napoli
Italy S. Maria della Pietà Nola

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of patients who experience BTcP one year
Primary treatments used to treat BTcP one year
Secondary pain intensity evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication 4 weeks
Secondary time to pain relief of BTcP 4 weeks
Secondary initial dose of therapy (in morphine equivalents) for BTcP to verify a correlation between initial dose for BTcP and daily dose of baseline pain therapy 4 weeks
Secondary effective dose for BTcP to verify a correlation between effective dose for BTcP and daily dose of baseline pain therapy (dose reported in morphine equivalents) 4 weeks
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