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NCT Number: NCT02836379

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

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.

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Key information

Conditions

Breakthrough Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Angelini Farmacéutica

Industry

Registry information

Official study title

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

Acronym: CAVIDIOR

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 19, 2016
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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