Treatment of Breakthrough Cancer Pain According to European Guidelines

Terminated

• Conditions: Breakthrough Cancer Pain

• Registration Number: NCT04468490
• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

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.

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Study Start: 2020-08-11
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 131

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.	4 weeks of observation	Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)

Secondary Outcome Measures

Name	Time	Method
APM algorithm	0, 1, 2, 3, 4 weeks of observation	BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)
EORTC QLQ-C30	at 0, 1, 2, 3, 4 weeks of observation	Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)
Patient Global Impression of Change (PGIC)	at 0, 2 and 4 weeks of observation	Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).
Tool-BAT	at 0, 1, 2, 3, 4 weeks of observation	BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)
Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)	at 2 and 4 weeks of observation	Number of admittances to ER due to cancer pain during the observation period
Healthcare resources consumed due to cancer pain (Number of hospitalizations)	at 2 and 4 weeks of observation	Number of hospitalizations due to cancer pain during the observation period
Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)	at 2 and 4 weeks of observation	Number of specialist/GP visits due to cancer pain during the observation period
Healthcare resources consumed due to cancer pain (Length of hospitalizations)	at 2 and 4 weeks of observation	Length of hospitalizations (days) due to cancer pain during the observation period

Trial Locations

Locations (1)

Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna; 🇵🇱 Dąbrowa Górnicza, Poland