Breakthrough PainCAVIDIORNCT02836379
Quality of Life Study Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
An observational study of Breakthrough Pain, run by Angelini Farmacéutica at 11 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Pain
- How many people
- 79 participants
- Where
- 11 sitesSpain
- Study dates
- 8 Jul 2016to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Centro Oncológico de galicia
A Coruña, 15009
Hospital de l'Esperança
Barcelona, 08024
ICO Hospitalet
Barcelona, 08908
Hospital Ramón y Cajal
Madrid, 28034
Hospital La Paz
Madrid, 28046
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Regional de Málaga
Málaga, 29010
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Virgen Macarena
Seville, 41007
Hospital de Terrassa
Terrassa, Barcelona, 08227
Hospital Do Meixoeiro
Vigo, Pontevedra, 36200
About this study
Official title: Quality of Life Study in Patients With 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.
- Conditions
- Breakthrough Pain
- Being tested
- No intervention
- Keywords
- Breakthrough Cancer Pain, Quality of life, Radiotherapy
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Breakthrough Cancer Pain | No intervention (Non-interventional study) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life according SF-12 questionnaire
Change in punctuation of the SF-12 questionnaire between end of radiotherapy treatment and baseline.
Measured: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Secondary outcomes (9)
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Percentage of patients with neuropathic, visceral, somatic and mixed pain
Measured: Baseline (the day that patient sign the informed consent form)
Comorbidities associated with patients
Percentage of patients with each comorbidity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study start8 Jul 2016
- Primary completionNov 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelini Farmacéutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Mañas, MD, Study director, IMONCOLOGY, Hospital la Milagrosa. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836379
- Sponsor's protocol ID
- ANG-DOL-2016-01 (CAVIDIOR)
- Acronym
- CAVIDIOR
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33289432
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Study in Patients With Breakthrough Cancer Pain Treated in Radiation Oncology Services With Palliative Intent
- ClinicalTrials.gov ID
- NCT02836379
- Acronym / sponsor ID
- CAVIDIOR / ANG-DOL-2016-01 (CAVIDIOR)
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough Cancer Pain, Quality of life, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Angelini FarmacéuticaIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breakthrough Cancer Pain | – | Other: No interventionNo intervention (Non-interventional study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breakthrough cancer pain treated in Radiation Oncology services with palliative intent will be included
Key inclusion criteria (6 listed)
- Patients > 18 years
- Cancer Patients
- Patients attended in radiation oncology consultations with palliative intent
- Life expectancy > 6 months
- Written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Breakthrough Cancer Pain |
Primary outcome
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.
9 secondary outcomes
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
Time frame: Baseline (the day that patient sign the informed consent form)
Mean time to 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 frame: Up to 6 weeks, from date of inclusion until the end of radiotherapy treatment
Clinical Global improvement
Time frame: 4-6 weeks (estimated end of radiotherapy treatment)
Patient Global improvement
Time frame: 4-6 weeks (estimated end of radiotherapy treatment)
Change in assessment (percentage) of family claudication
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
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
Change in MOS Sleep Scale scores
Time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Derived from this study: PubMed 33289432Hernanz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Mañas, MD study director
IMONCOLOGY, Hospital la Milagrosa. Madrid
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Pain, run by Angelini Farmacéutica at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life according SF-12 questionnaire (time frame: Baseline and 4-6 weeks (estimated end of radiotherapy treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02836379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.