An observational study in Breakthrough Pain, sponsored by Angelini Farmacéutica. Completed at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Angelini Farmacéutica (part of Angelini Pharma) · Observational
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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 79 is below the median of 125 across 10 observational studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Angelini Farmacéutica is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention (Non-interventional study)
Other: No intervention
No intervention
Change in quality of life according SF-12 questionnaire
Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Time frame: Baseline (the day that patient sign the informed consent form)
Comorbidities associated with patients
Percentage of patients with each comorbidity
Time frame: Baseline (the day that patient sign the informed consent form)
Mean time to relief of breakthrough pain
Time from the start of the episode until the relief of breakthrough pain
Time frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Mean duration of the episodes of breakthrough pain
Time from the start of the episode until the pain ends
Time frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Clinical Global improvement
Number of patients indicating each of the possible answers of the Clinical Global Impression of improvement scale
Time frame: 4-6 weeks (estimated end of radiotherapy treatment)
Patient Global improvement
Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale
Time frame: 4-6 weeks (estimated end of radiotherapy treatment)
Change in assessment (percentage) of family claudication
Difference in percentage of patients with punctuation ≥ 17 points at end of radiotherapy treatment and baseline.
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
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.
Time frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Change in MOS Sleep Scale scores
Change in MOS Sleep Scale scores between end of radiotherapy treatment and baseline
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Plan to share: No
Ran from Jul 2016 to primary completion in Nov 2017, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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