Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

Breakthrough Pain Clinical Trial

— CAVIDIOR  

Official title:

Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836379
• Other study ID #: ANG-DOL-2016-01 (CAVIDIOR)
• Status: Completed
• Phase: N/A
• First received: July 11, 2016
• Last updated: March 2, 2018
• Start date: July 8, 2016
• Est. completion date: February 28, 2018

Study information

• Verified date: March 2018
• Source: Angelini Farmacéutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 28, 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Cancer Pain

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Centro Oncológico de galicia	A Coruña
Spain	Hospital de l'Esperança	Barcelona
Spain	ICO Hospitalet	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Regional de Málaga	Málaga
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital de Terrassa	Terrassa	Barcelona
Spain	Hospital Do Meixoeiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Angelini Farmacéutica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life according SF-12 questionnaire	Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.	Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Secondary	Percentage of patients with neuropathic, visceral, somatic and mixed pain	Percentage of patients with neuropathic, visceral, somatic and mixed pain	Baseline (the day that patient sign the informed consent form)
Secondary	Comorbidities associated with patients	Percentage of patients with each comorbidity	Baseline (the day that patient sign the informed consent form)
Secondary	Mean time to relief of breakthrough pain	Time from the start of the episode until the relief of breakthrough pain	Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Secondary	Mean duration of the episodes of breakthrough pain	Time from the start of the episode until the pain ends	Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Secondary	Clinical Global improvement	Number of patients indicating each of the possible answers of the Clinical Global Impression of improvement scale	4-6 weeks (estimated end of radiotherapy treatment)
Secondary	Patient Global improvement	Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale	4-6 weeks (estimated end of radiotherapy treatment)
Secondary	Change in assessment (percentage) of family claudication	Difference in percentage of patients with punctuation = 17 points at end of radiotherapy treatment and baseline.	Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Secondary	Change in mean Intensity of breakthrough cancer pain at each study visit	Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.	Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Secondary	Change in MOS Sleep Scale scores	Change in MOS Sleep Scale scores between end of radiotherapy treatment and baseline	Baseline and 4-6 weeks (estimated end of radiotherapy treatment)