Breakthrough Cancer PainBEGNCT04468490
Treatment of Breakthrough Cancer Pain According to European Guidelines
An observational study of Breakthrough Cancer Pain, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Poland.
Trial summary
Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breakthrough Cancer Pain
- How many people
- 131 participants
- Where
- 1 sitePoland
- Study dates
- 11 Aug 2020to 30 Sep 2021
- 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: The study population includes patients with BTcP.
Who may be able to join
- Male and female patients of any ethnic origin of ≥ 18 years.
- Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator.
- Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg.
- Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.
- Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
- Patients with life expectancy > 3 months.
- Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
Who cannot join
- Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results.
- Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled.
- Any medical condition or situation complicating the collection of study data, as determined by the Investigator.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna
Dąbrowa Górnicza, 41-300
About this study
Official title: Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.
Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.
Read the detailed description
Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.
The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Breakthrough cancer pain, Cancer, BTcP, Background pain
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A: Patients adherent to BTcP European Guidelines | Not described | |
| GROUP B: Patients non Adherent to BTcP European Guidelines | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)
Measured: 4 weeks of observation
Secondary outcomes (8)
APM algorithm
BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)
Measured: 0, 1, 2, 3, 4 weeks of observation
Tool-BAT
BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)
Measured: at 0, 1, 2, 3, 4 weeks of observation
EORTC QLQ-C30
Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)
Measured: at 0, 1, 2, 3, 4 weeks of observation
Patient Global Impression of Change (PGIC)
Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).
Measured: at 0, 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)
Number of specialist/GP visits due to cancer pain during the observation period
Measured: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of hospitalizations)
Number of hospitalizations due to cancer pain during the observation period
Measured: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Length of hospitalizations)
Length of hospitalizations (days) due to cancer pain during the observation period
Measured: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)
Number of admittances to ER due to cancer pain during the observation period
Measured: at 2 and 4 weeks of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start11 Aug 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: Low enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough Cancer 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
- Other
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468490
- Sponsor's protocol ID
- 155(A)WO19191
- Acronym
- BEG
- Status last verified
- Oct 2021
- First submitted
- 1 Jul 2020
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT04468490
- Acronym / sponsor ID
- BEG / 155(A)WO19191
- Conditions
- Breakthrough Cancer Pain
- Keywords
- Breakthrough cancer pain, Cancer, BTcP, Background pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment rate
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- 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.
Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.
Detailed description
Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.
The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A: Patients adherent to BTcP European Guidelines | – | – |
| GROUP B: Patients non Adherent to BTcP European Guidelines | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with BTcP.
Key inclusion criteria (7 listed)
- Male and female patients of any ethnic origin of ≥ 18 years.
- Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator.
- Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg.
- Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.
- Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2.
Key exclusion criteria (3 listed)
- Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results.
- Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled.
- Any medical condition or situation complicating the collection of study data, as determined by the Investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
Time frame: 4 weeks of observation
Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)
8 secondary outcomes
APM algorithm
Time frame: 0, 1, 2, 3, 4 weeks of observation
Tool-BAT
Time frame: at 0, 1, 2, 3, 4 weeks of observation
EORTC QLQ-C30
Time frame: at 0, 1, 2, 3, 4 weeks of observation
Patient Global Impression of Change (PGIC)
Time frame: at 0, 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)
Time frame: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of hospitalizations)
Time frame: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Length of hospitalizations)
Time frame: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)
Time frame: at 2 and 4 weeks of observation
Results and safety
The study was stopped early (reason given: Low enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Breakthrough Cancer Pain
Recruiting
Doxepin Solution for Alleviation of Stubborn Breakthrough Pain Induced by Swallowing in Patients Receiving Radiotherapy for Nasopharyngeal Carcinoma
Swallowing-induced Pain
Not yet recruitingObservational study
Paediatric Breakthrough Pain Assessment
Breakthrough Pain, Palliative Medicine
RecruitingObservational study
A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis
Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
RecruitingObservational study
A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis
Radiation-induced Oropharyngeal Mucositis, Swallowing-induced Breakthrough Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breakthrough Cancer Pain, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in Poland.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 was stopped early (reason given: Low enrollment rate). Results are not available in the source record.
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?
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP. (time frame: 4 weeks of observation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2021.