Treatment of Breakthrough Cancer Pain According to European Guidelines (BEG)

Angelini Pharma

Status: Terminated

Conditions: Breakthrough Cancer Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT04468490

155(A)WO19191

Details and patient eligibility

About

Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Full description

Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.

The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients of any ethnic origin of ≥ 18 years.
• Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator.
• Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg.
• Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.
• Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
• Patients with life expectancy > 3 months.
• Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.

Exclusion criteria

• Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results.
• Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled.
• Any medical condition or situation complicating the collection of study data, as determined by the Investigator.

Trial design

131 participants in 2 patient groups

GROUP A: Patients adherent to BTcP European Guidelines

GROUP B: Patients non Adherent to BTcP European Guidelines