Advanced CancerBreak-1NCT02069067
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated
An observational study of Advanced Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.
Trial summary
The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- How many people
- 500 participants
- Where
- 3 sitesItaly
- Study dates
- Dec 2011to Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced cancer and chronic pain being controlled with opiods.
Who may be able to join
- Diagnosis of neoplasm in advanced stage
- Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent
- 1-6 episodes of BTcP within any of 3 days previous to registration into study
- Signed Informed Consent
Who cannot join
- More than 6 episodes of BTcP within any of 3 days previous to registration into study
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale San Leonardo
Castellammare di Stabia
Istituto Nazionale dei Tumori , Unita Terapia Antalgica
Naples
S. Maria della Pietà
Nola
About this study
Official title: Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain
The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.
- Conditions
- Advanced Cancer
- Keywords
- breakthrough cancer pain, pain, neuropathic pain, intractable pain, cancer
- Medical subject headings
- Pain, Neuralgia, Pain, Intractable, 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 |
|---|---|---|
| Advanced cancer patients with pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who experience BTcP
Measured: one year
treatments used to treat BTcP
Measured: one year
Secondary outcomes (4)
pain intensity
evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication
Measured: 4 weeks
time to pain relief of BTcP
Measured: 4 weeks
initial dose of therapy (in morphine equivalents) for BTcP
to verify a correlation between initial dose for BTcP and daily dose of baseline pain therapy
Measured: 4 weeks
effective dose for BTcP
to verify a correlation between effective dose for BTcP and daily dose of baseline pain therapy (dose reported in morphine equivalents)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arturo Cuomo, M.D., Principal investigator, NCI Naples, Division of Pain TherapyFrancesco Perrone, M.D., Ph.D., Principal investigator, NCI Naples, Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069067
- Sponsor's protocol ID
- Break-1
- Acronym
- Break-1
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2014
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain
- ClinicalTrials.gov ID
- NCT02069067
- Acronym / sponsor ID
- Break-1 / Break-1
- Conditions
- Advanced Cancer
- Keywords
- breakthrough cancer pain, pain, neuropathic pain, intractable pain, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Feb 2014 (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.
The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced cancer patients with pain | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced cancer and chronic pain being controlled with opiods.
Key inclusion criteria (4 listed)
- Diagnosis of neoplasm in advanced stage
- Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent
- 1-6 episodes of BTcP within any of 3 days previous to registration into study
- Signed Informed Consent
Key exclusion criteria (1 listed)
- More than 6 episodes of BTcP within any of 3 days previous to registration into study
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
number of patients who experience BTcP
Time frame: one year
treatments used to treat BTcP
Time frame: one year
4 secondary outcomes
pain intensity
Time frame: 4 weeks
time to pain relief of BTcP
Time frame: 4 weeks
initial dose of therapy (in morphine equivalents) for BTcP
Time frame: 4 weeks
effective dose for BTcP
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Arturo Cuomo, M.D. principal investigator
NCI Naples, Division of Pain Therapy
Francesco Perrone, M.D., Ph.D. principal investigator
NCI Naples, Clinical Trials Unit
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer, run by National Cancer Institute, Naples at 3 sites in Italy.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
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?
number of patients who experience BTcP (time frame: one year). The study lists 2 primary outcomes in all. 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 24 Mar 2023.