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

National Cancer Institute, Naples

Status: Active, not recruiting

Conditions: Advanced Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02069067

Break-1

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Advanced cancer patients with pain