Clinical trial · Observational
Treatment of Breakthrough Cancer Pain According to European Guidelines
Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breakthrough Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- GROUP A: Patients adherent to BTcP European Guidelines
- label
- GROUP B: Patients non Adherent to BTcP European Guidelines
Primary outcomes (1)
- measure
- Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
- timeFrame
- 4 weeks of observation
- description
- Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)
Secondary outcomes (8)
- measure
- APM algorithm
- timeFrame
- 0, 1, 2, 3, 4 weeks of observation
- description
- BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available