Clinical trial NCT02836379: Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
Official title: Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Pain
Keywords: Breakthrough Cancer Pain
Quality of life
Radiotherapy
Lead sponsor: Angelini Farmacéutica
Sponsor class: INDUSTRY
First posted: 2016-07-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in quality of life according SF-12 questionnaire
timeFrame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Secondary outcomes:
measure: Percentage of patients with neuropathic, visceral, somatic and mixed pain
timeFrame: Baseline (the day that patient sign the informed consent form)
measure: Comorbidities associated with patients
timeFrame: Baseline (the day that patient sign the informed consent form)
measure: Mean time to relief of breakthrough pain
timeFrame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
measure: Mean duration of the episodes of breakthrough pain
timeFrame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
measure: Clinical Global improvement
timeFrame: 4-6 weeks (estimated end of radiotherapy treatment)
measure: Patient Global improvement
timeFrame: 4-6 weeks (estimated end of radiotherapy treatment)
measure: Change in assessment (percentage) of family claudication
timeFrame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
measure: Change in mean Intensity of breakthrough cancer pain at each study visit
timeFrame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
measure: Change in MOS Sleep Scale scores
timeFrame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: A Coruña
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Vigo
country: Spain
facility: Hospital Do Meixoeiro
state: Pontevedra
city: A Coruña
country: Spain
facility: Centro Oncológico de galicia
city: Barcelona
country: Spain
facility: Hospital de l'Esperança
city: Barcelona
country: Spain
facility: ICO Hospitalet
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital La Paz
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
affiliation: IMONCOLOGY, Hospital la Milagrosa. Madrid
name: Ana Mañas, MD
role: STUDY_DIRECTOR
References:
citation: Hernanz 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.