Clinical trial · Observational
Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial. There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain treated in palliative care units as well as the characteristics of these patients. This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.
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 Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breakthrough Cancer Pain
- description
- No intervention (Non-interventional study)
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Change in quality of life according EORTC QLQ-C30 questionnaire
- timeFrame
- Baseline and 4 weeks
- description
- Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.
Secondary outcomes (8)
- measure
- Percentage of patients with neuropathic, visceral, somatic and mixed pain
- timeFrame
- Baseline (the day that patient sign the informed consent form)
- description
- Percentage of patients with neuropathic, visceral, somatic and mixed pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years * Patients with advanced cancer * Patients attended in Palliative Care Units * Life expectancy\> 3 months * Written informed consent * Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm Exclusion Criteria: * Serious psychiatric disorder, cognitive impairment or any disease or condition that prevents the collection of data * Patients with evidence of opioid addiction or history of drug or alcohol abuse
References
Publications (2)
- DERIVEDRodriguez AT, Viejo MN, Maradey P, Canal-Sotelo J, Mancilla PG, Rivero SG, Casillas IR, Abian MH, Bermudo CL. Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. Future Oncol. 2022 May;18(14):1717-1731. doi: 10.2217/fon-2021-1639. Epub 2022 Feb 9. PMID 35137627
- DERIVEDTuca Rodriguez A, Nunez Viejo M, Maradey P, Canal-Sotelo J, Guardia Mancilla P, Gutierrez Rivero S, Raja Casillas I, Herrera Abian M, Lopez Bermudo C. Impact of individualized management of breakthrough cancer pain on quality of life in advanced cancer patients: CAVIDIOPAL study. Support Care Cancer. 2021 Aug;29(8):4799-4807. doi: 10.1007/s00520-021-06006-1. Epub 2021 Feb 3. PMID 33533986