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

NCT ID: NCT02069067

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Advanced cancer patients with pain

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Naples

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arturo Cuomo, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Pain Therapy

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Clinical Trials Unit

Locations

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Ospedale San Leonardo

Castellammare di Stabia, , Italy

Site Status

Istituto Nazionale dei Tumori , Unita Terapia Antalgica

Napoli, , Italy

Site Status

S. Maria della Pietà

Nola, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Break-1

Identifier Type: -

Identifier Source: org_study_id

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