Breakthrough PainCAVIDIOPALNCT02840500
Quality of Life Study in Patients With Cancer Breakthrough Pain Treated in Palliative Care Units
An observational study of Breakthrough Pain, run by Angelini Farmacéutica at 10 sites in Spain.
Trial summary
Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in 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
- 101 participants
- Where
- 10 sitesSpain
- Study dates
- 27 Jun 2016to Mar 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 attended in Palliative Care Units will be included
Who may be able to join
- Patients > 18 years
- Patients with advanced cancer
- Patients attended in Palliative Care Units
- Life expectancy> 3 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
- Serious psychiatric disorder, cognitive impairment 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
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Clínic
Barcelona, 08036
Hospital Virgen de las Nieves
Granada, 18014
Hospital Arnau de Vilanova
Lleida, 25198
Hospital Gregorio Marañón
Madrid, 28007
Fundación Jiménez Díaz
Madrid, 28040
Hospital de Mollet
Mollet del Vallès, Barcelona, 08100
Complejo Hospitalario de Ourense
Ourense, 32005
Hospital Sant Joan de Deu
Palma, Illes Baleares, 07007
Hospital Virgen del Rocío
Seville, 41013
Hospital Virgen de la Salud
Toledo, 45005
About this study
Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial.
There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain treated in palliative care units as well as the characteristics of these patients.
This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units in Spanish hospitals.
- Conditions
- Breakthrough Pain
- Being tested
- No intervention
- Keywords
- Breakthrough Cancer Pain, Quality of life, Palliative Care Units
- 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 EORTC QLQ-C30 questionnaire
Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.
Measured: Baseline and 4 weeks
Secondary outcomes (8)
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)
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 4 weeks, from date of inclusion until week 4
Mean time to relief of breakthrough pain
Time from the start of the episode until the relief of breakthrough pain
Measured: Up to 4 weeks, from date of inclusion until week 4
Mean duration of the episodes of breakthrough pain
Time from the start of the episode until the pain ends
Measured: Up to 4 weeks, from date of inclusion until week 4
Patient Global improvement
Number of patients indicating each of the possible answers of the Patient Global Impression of improvement scale (7-points Likert scale)
Measured: Week 4
Percentage of fragile patients at study entry
Frailty of patients will be assessed by Edmonton Symptom Assessment System (ESAS). It is considered that a patient is fragile when the symptom score is greater than 4 (moderate intensity) in five or more symptoms.
Measured: Baseline
Cognitive impairment
Cognitive impairment (Pfeiffer test): 0-2 errors: intact cognition; 3-4 errors: mild impairment; 5-7 errors: moderate impairment; 8-10 errors: severe impairment. Percentage of patients in each category
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start27 Jun 2016
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angelini Farmacéutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Tuca, MD, Study director, Hospital Clinic de Barcelona, Palliative Care Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840500
- Sponsor's protocol ID
- ANG-OPI-2016-01 (CAVIDIOPAL)
- Acronym
- CAVIDIOPAL
- Status last verified
- Mar 2018
- First submitted
- 19 Jul 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rodriguez AT, Viejo MN, Maradey P, Canal-Sotelo J, Mancilla PG, Rivero SG, Casillas IR, Abian MH, Bermudo CL. Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. Future Oncol. 2022 May;18(14):1717-1731. doi: 10.2217/fon-2021-1639. Epub 2022 Feb 9.
PubMed 35137627Tuca Rodriguez A, Nunez Viejo M, Maradey P, Canal-Sotelo J, Guardia Mancilla P, Gutierrez Rivero S, Raja Casillas I, Herrera Abian M, Lopez Bermudo C. Impact of individualized management of breakthrough cancer pain on quality of life in advanced cancer patients: CAVIDIOPAL study. Support Care Cancer. 2021 Aug;29(8):4799-4807. doi: 10.1007/s00520-021-06006-1. Epub 2021 Feb 3.
PubMed 33533986
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 Cancer Breakthrough Pain Treated in Palliative Care Units
- ClinicalTrials.gov ID
- NCT02840500
- Acronym / sponsor ID
- CAVIDIOPAL / ANG-OPI-2016-01 (CAVIDIOPAL)
- Conditions
- Breakthrough Pain
- Keywords
- Breakthrough Cancer Pain, Quality of life, Palliative Care Units
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Angelini FarmacéuticaIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 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.
Patients treated in Palliative Care Units are potentially fragile patients, especially in our case, which are cancer patients. The management of these patients is usually done from experience, because these patients rarely meet criteria for clinical trials, as their inclusion could affect results obtained in the trial.
There is insufficient clinical information on the quality of life of cancer patients with breakthrough pain treated in palliative care units according to routine clinical practice. For this reason we consider it is appropriate to prospectively evaluate the quality of life of cancer patients with cancer breakthrough pain treated in palliative care units as well as the characteristics of these patients.
This post-authorization observational study will assess the quality of life of patients with breakthrough cancer pain treated in Palliative Care Units 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 attended in Palliative Care Units will be included
Key inclusion criteria (6 listed)
- Patients > 18 years
- Patients with advanced cancer
- Patients attended in Palliative Care Units
- Life expectancy> 3 months
- Written informed consent
Key exclusion criteria (2 listed)
- Serious psychiatric disorder, cognitive impairment 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 EORTC QLQ-C30 questionnaire
Time frame: Baseline and 4 weeks
Change in punctuation of the EORTC QLQ-C30 questionnaire between week 4 and baseline.
8 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)
Change in mean Intensity of breakthrough cancer pain at each study visit
Time frame: Up to 4 weeks, from date of inclusion until week 4
Mean time to relief of breakthrough pain
Time frame: Up to 4 weeks, from date of inclusion until week 4
Mean duration of the episodes of breakthrough pain
Time frame: Up to 4 weeks, from date of inclusion until week 4
Patient Global improvement
Time frame: Week 4
Percentage of fragile patients at study entry
Time frame: Baseline
Cognitive impairment
Time frame: Baseline
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 35137627Rodriguez AT, Viejo MN, Maradey P, Canal-Sotelo J, Mancilla PG, Rivero SG, Casillas IR, Abian MH, Bermudo CL. Low-dose sublingual fentanyl improves quality of life in patients with breakthrough cancer pain in palliative care. Future Oncol. 2022 May;18(14):1717-1731. doi: 10.2217/fon-2021-1639. Epub 2022 Feb 9.
- Derived from this study: PubMed 33533986Tuca Rodriguez A, Nunez Viejo M, Maradey P, Canal-Sotelo J, Guardia Mancilla P, Gutierrez Rivero S, Raja Casillas I, Herrera Abian M, Lopez Bermudo C. Impact of individualized management of breakthrough cancer pain on quality of life in advanced cancer patients: CAVIDIOPAL study. Support Care Cancer. 2021 Aug;29(8):4799-4807. doi: 10.1007/s00520-021-06006-1. Epub 2021 Feb 3.
- 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.
Albert Tuca, MD study director
Hospital Clinic de Barcelona, Palliative Care Unit
10 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 10 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 2 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 10 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 EORTC QLQ-C30 questionnaire (time frame: Baseline and 4 weeks). 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 NCT02840500, which also lists 2 linked publications.
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.