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

N/AUnknownNCT02069067

National Cancer Institute, Naples500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Advanced Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (3)

Ospedale San Leonardo

Castellammare di Stabia, Italy

Istituto Nazionale dei Tumori , Unita Terapia Antalgica

Napoli, Italy

S. Maria della Pietà

Nola, Italy

Outcomes

Primary Outcomes

number of patients who experience BTcP

Time frame: one year

treatments used to treat BTcP

Time frame: one year

Secondary Outcomes

pain intensity

evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication

Time frame: 4 weeks

time to pain relief of BTcP

Time frame: 4 weeks

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

Time frame: 4 weeks

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)

Time frame: 4 weeks

Data from ClinicalTrials.gov

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