Treatment of Breakthrough Cancer Pain According to European Guidelines

NCT ID: NCT04468490

Last Updated: 2021-10-27

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2021-09-30

Brief Summary

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.

Detailed 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.

Conditions

Breakthrough Cancer Pain

Keywords

Breakthrough cancer pain; Cancer; BTcP; Background pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

GROUP A: Patients adherent to BTcP European Guidelines

No interventions assigned to this group

GROUP B: Patients non Adherent to BTcP European Guidelines

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna

Dąbrowa Górnicza, , Poland

Countries

Poland

Other Identifiers

155(A)WO19191

Identifier Type: -

Identifier Source: org_study_id