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

Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069067

Acronym

Break-1

Enrollment

500

Registered

2014-02-21

Start date

2011-12-31

Completion date

2023-12-31

Last updated

2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

Keywords

breakthrough cancer pain, pain, neuropathic pain, intractable pain, cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
number of patients who experience BTcP	one year
treatments used to treat BTcP	one year

Secondary

Measure	Time frame	Description
pain intensity	4 weeks	evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication
time to pain relief of BTcP	4 weeks	—
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
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)

Countries

Italy

Outcome results