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
• Status: Active, not recruiting
• 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
• 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:

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

Related Conditions & MeSH terms

• Advanced Cancer
• Cancer Pain

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