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

Active, not recruiting

• Conditions: Advanced Cancer

• Registration Number: NCT02069067
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
treatments used to treat BTcP	one year
number of patients who experience BTcP	one year

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Ospedale San Leonardo; 🇮🇹 Castellammare di Stabia, Italy

Istituto Nazionale dei Tumori , Unita Terapia Antalgica; 🇮🇹 Napoli, Italy

S. Maria della Pietà; 🇮🇹 Nola, Italy