Clinical trial · Observational
Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
- 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)
In the context of radiotherapy, control of breakthrough pain represents a special challenge. Patients undergoing radiotherapy may experience different situations of pain that may be due to the need to remain immobilized during radiotherapy session, the need to wear an immobilization mask (head and neck cancer), the odynophagia caused by mucositis, defecation after the development of proctitis, or sudden pain during the night causing sleep disturbances. In a survey conducted in radiation oncology services more than half of patients treated with radiotherapy experienced pain, and 39% of patients reported that their pain was not treated properly. This situation may increase the patient's anxiety, dissatisfaction with treatment, affect their quality of life and can even come to refuse radiotherapy treatment. This post-authorization observational study will assess the quality of life of cancer patients with breakthrough cancer pain treated in radiotherapy services 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 SF-12 questionnaire
- timeFrame
- Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
- description
- Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.
Secondary outcomes (9)
- measure
- Percentage of patients with neuropathic, visceral, somatic and mixed pain
- timeFrame
- Baseline (the day that patient sign the informed consent form)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years * Cancer Patients * Patients attended in radiation oncology consultations with palliative intent * Life expectancy \> 6 months * Written informed consent * Patients with baseline controlled cancer pain with opioids who are diagnosed of breakthrough cancer pain by Davies algorithm Exclusion Criteria: * Untreated patients with opioids for baseline pain * Patients who are not opioid tolerant * Serious psychiatric disorder 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 (1)
- DERIVEDHernanz de Lucas R, Nunez Fernandez M, Gomez-Caamano A, Morera Lopez R, Fortes de la Torre I, de la Torre Tomas A, Munoz-Garzon V, Lopez Bermudo C, Manas Rueda A. Quality of life in patients with breakthrough cancer pain in radiation oncology departments in Spain: the CAVIDIOR study. Future Oncol. 2021 Mar;17(8):943-954. doi: 10.2217/fon-2020-1063. Epub 2020 Dec 8. PMID 33289432