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

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ClinicalTrials.gov Identifier: NCT02836379
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Angelini Farmacéutica

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.


Condition or disease Intervention/treatment
Breakthrough Pain Other: No intervention

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
Actual Study Start Date : July 8, 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : February 28, 2018

Group/Cohort Intervention/treatment
Breakthrough Cancer Pain
No intervention (Non-interventional study)
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Change in quality of life according SF-12 questionnaire [ Time Frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment) ]
    Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.


Secondary Outcome Measures :
  1. Percentage of patients with neuropathic, visceral, somatic and mixed pain [ Time Frame: Baseline (the day that patient sign the informed consent form) ]
    Percentage of patients with neuropathic, visceral, somatic and mixed pain

  2. Comorbidities associated with patients [ Time Frame: Baseline (the day that patient sign the informed consent form) ]
    Percentage of patients with each comorbidity

  3. Mean time to relief of breakthrough pain [ Time Frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment ]
    Time from the start of the episode until the relief of breakthrough pain

  4. Mean duration of the episodes of breakthrough pain [ Time Frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment ]
    Time from the start of the episode until the pain ends

  5. Clinical Global improvement [ Time Frame: 4-6 weeks (estimated end of radiotherapy treatment) ]
    Number of patients indicating each of the possible answers of the Clinical Global Impression of improvement scale

  6. Patient Global improvement [ Time Frame: 4-6 weeks (estimated end of radiotherapy treatment) ]
    Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale

  7. Change in assessment (percentage) of family claudication [ Time Frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment) ]
    Difference in percentage of patients with punctuation ≥ 17 points at end of radiotherapy treatment and baseline.

  8. Change in mean Intensity of breakthrough cancer pain at each study visit [ Time Frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment ]
    Intensity of breakthrough cancer pain assessed with a Visual Analog Scale (VAS). VAS will be compared at each study visit.

  9. Change in MOS Sleep Scale scores [ Time Frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment) ]
    Change in MOS Sleep Scale scores between end of radiotherapy treatment and baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836379


Locations
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Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, Spain, 15706
Hospital de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Do Meixoeiro
Vigo, Pontevedra, Spain, 36200
Centro Oncológico de galicia
A Coruña, Spain, 15009
Hospital de l'Esperança
Barcelona, Spain, 08024
ICO Hospitalet
Barcelona, Spain, 08908
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital La Paz
Madrid, Spain, 28046
Hospital Regional de Málaga
Málaga, Spain, 29010
Hospital Virgen Macarena
Sevilla, Spain, 41007
Sponsors and Collaborators
Angelini Farmacéutica
Investigators
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Study Director: Ana Mañas, MD IMONCOLOGY, Hospital la Milagrosa. Madrid
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Responsible Party: Angelini Farmacéutica
ClinicalTrials.gov Identifier: NCT02836379    
Other Study ID Numbers: ANG-DOL-2016-01 (CAVIDIOR)
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Angelini Farmacéutica:
Breakthrough Cancer Pain
Quality of life
Radiotherapy
Additional relevant MeSH terms:
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Cancer Pain
Breakthrough Pain
Pain
Neurologic Manifestations
Signs and Symptoms