Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated (Break-1)

March 23, 2023 updated by: National Cancer Institute, Naples

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Castellammare di Stabia, Italy
        • Ospedale San Leonardo
      • Napoli, Italy
        • Istituto Nazionale dei Tumori , Unita Terapia Antalgica
      • Nola, Italy
        • S. Maria della Pietà

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced cancer and chronic pain being controlled with opiods.

Description

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:

· More than 6 episodes of BTcP within any of 3 days previous to registration into study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Advanced cancer patients with pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients who experience BTcP
Time Frame: one year
one year
treatments used to treat BTcP
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: 4 weeks
evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication
4 weeks
time to pain relief of BTcP
Time Frame: 4 weeks
4 weeks
initial dose of therapy (in morphine equivalents) for BTcP
Time Frame: 4 weeks
to verify a correlation between initial dose for BTcP and daily dose of baseline pain therapy
4 weeks
effective dose for BTcP
Time Frame: 4 weeks
to verify a correlation between effective dose for BTcP and daily dose of baseline pain therapy (dose reported in morphine equivalents)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Investigators

  • Principal Investigator: Arturo Cuomo, M.D., NCI Naples, Division of Pain Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Break-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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