Clinical trial NCT04468490: Treatment of Breakthrough Cancer Pain According to European Guidelines
Official title: Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breakthrough Cancer Pain
Keywords: Breakthrough cancer pain
Cancer
BTcP
Background pain
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients with BTcP.

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.

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.

Primary outcomes:
measure: Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
timeFrame: 4 weeks of observation
Secondary outcomes:
measure: APM algorithm
timeFrame: 0, 1, 2, 3, 4 weeks of observation
measure: Tool-BAT
timeFrame: at 0, 1, 2, 3, 4 weeks of observation
measure: EORTC QLQ-C30
timeFrame: at 0, 1, 2, 3, 4 weeks of observation
measure: Patient Global Impression of Change (PGIC)
timeFrame: at 0, 2 and 4 weeks of observation
measure: Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)
timeFrame: at 2 and 4 weeks of observation
measure: Healthcare resources consumed due to cancer pain (Number of hospitalizations)
timeFrame: at 2 and 4 weeks of observation
measure: Healthcare resources consumed due to cancer pain (Length of hospitalizations)
timeFrame: at 2 and 4 weeks of observation
measure: Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)
timeFrame: at 2 and 4 weeks of observation
Other outcomes:
Locations:
city: Dąbrowa Górnicza
country: Poland
facility: Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna
Study officials:
References: