Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
NCT ID: NCT01946555
Last Updated: 2016-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2013-09-30
2015-12-31
Brief Summary
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The BTP is a common clinical features in patients with cancer pain (BTcP: breakthrough cancer pain). The prevalence of BTcP is equal to 56%.
Currently, the investigators tend to recognize the idiopathic/spontaneous or accident BTcP in the three sub-types: voluntary, non- voluntary and procedural.
The diagnosis of BTCP is not always easy because in the cancer patient is normal to observe changes in the intensity of pain during the day, so it is necessary to differentiate slight fluctuations from the presence of real episodes of BTCP, for which is necessary to use a rescue treatment adjusted. In the study will be proposed the use of a diagnostic algorithm, present in the literature, to perform the diagnosis of BTCP.
In the presence of BTCP, is important both a correct controlled background pain with major opioids, which can reduce the number and the intensity of the painful episodes, both implement an adjunctive therapy, called "rescue", to be administered at the time which takes over the painful episode using, in this case, an opioid greater.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Worst pain, Average pain
It is necessary that patients are treated for their baseline pain with opioid medications 3rd step (WHO guidelines), having seven different provisions molecules (morphine, methadone, fentanyl, buprenorphine, oxycodone, hydromorphone and tapentadol), and that they receive opioid rescue medication, based on free choice among the options available on the market (in the form of transmucosal fentanyl: OTFC - lollipop, buccal buccal tablets, sublingual tablets, nasal spray in aqueous solution, with pectin nasal spray, morphine or other opioid "oral immediate release" or intravenously).
Morphine
Fentanyl
Methadone
Buprenorphine
Oxycodone
Hydromorphone
Tapentadol
Interventions
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Morphine
Fentanyl
Methadone
Buprenorphine
Oxycodone
Hydromorphone
Tapentadol
Eligibility Criteria
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Inclusion Criteria
* presence of baseline pain of moderate intensity / severe, necessitating treatment with opioids of the 3rd step / WHO, already in progress or to be undertaken at a stage just prior to the start of the study (see also criterion 4 where indicates that "the pain of base must be adequately controlled with opioids of the wHO 3rd step");
* estimated life expectancy of more than one month;
* presence of BTCP, diagnosed according to the criteria set by the definition of BTCP and the algorithm of Davies, for which it is established to undertake a treatment "rescue" of painful episodes, with the appropriate opioid drugs at the time of commencement of the study;
* capable of taking opioid medications for pain basic and breakthrough pain, by any route of administration;
* aged more than 18 years.
Exclusion Criteria
* absence of informed consent, or withdrawal of consent for study participation;
* presence of some pathological mental or psychiatric conditions, due to the tumor or concomitant diseases, which interfere with the state of consciousness or the ability to judge the point of jeopardizing the study protocol;
* need treatment for comorbid conditions present at the beginning of the study that could create potentially dangerous drug interactions with opioids (conazolici use of antifungals or macrolide antibiotics);
* contraindications of any kind for use of opioid drugs;
* positivity of a story, past or current, of substance abuse;
* inability to ensure regular follow-up;
* diagnosis of primary tumor of the brain;
* situation of the presence of BTCP already in treatment with opioid rescue of 3rd step;
* decision to use drugs "rescue" of different opioid 3rd step / WHO (NSAIDs, opioids of 2 ° step), for the treatment of BTCP;
* diagnosis of chronic renal failure proclaimed already in place, with values of blood creatinine ≥ 2 mg / dL.
18 Years
99 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Oscar Corli, MD
Role: PRINCIPAL_INVESTIGATOR
Mario Negri Institute of Pharmacological Research - IRCCS
Locations
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AO Universitaria Policlinico di Modena
Modena, Italia, Italy
A.O. Universitaria Parma
Parma, Italia, Italy
Ospedale Magati
Scandiano, Italia, Italy
Azienda USL - Ospedale di Carpi e Mirandola
Carpi, , Italy
A.O.U. Arcispedale S. Anna
Ferrara, , Italy
Ospedale di Fiorenzuola D'Arda
Fiorenzuola d'Arda, , Italy
Ospedale di Lugo
Lugo, , Italy
IRCCS-IRST Forlì
Meldola, , Italy
Ospedale di Piacenza
Piacenza, , Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera
Reggio Emilia, , Italy
Ospedale degli Infermi
Rimini, , Italy
Countries
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References
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Portenoy RK, Hagen NA. Breakthrough pain: definition and management. Oncology (Williston Park). 1989 Aug;3(8 Suppl):25-9.
Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990 Jun;41(3):273-281. doi: 10.1016/0304-3959(90)90004-W.
Davies AN. Cancer-related breakthrough pain. Br J Hosp Med (Lond). 2006 Aug;67(8):414-6. doi: 10.12968/hmed.2006.67.8.21960.
Greco MT, Corli O, Montanari M, Deandrea S, Zagonel V, Apolone G; Writing Protocol Committee; Cancer Pain Outcome Research Study Group (CPOR SG) Investigators. Epidemiology and pattern of care of breakthrough cancer pain in a longitudinal sample of cancer patients: results from the Cancer Pain Outcome Research Study Group. Clin J Pain. 2011 Jan;27(1):9-18. doi: 10.1097/AJP.0b013e3181edc250.
Deandrea S, Corli O, Consonni D, Villani W, Greco MT, Apolone G. Prevalence of breakthrough cancer pain: a systematic review and a pooled analysis of published literature. J Pain Symptom Manage. 2014 Jan;47(1):57-76. doi: 10.1016/j.jpainsymman.2013.02.015. Epub 2013 Jun 21.
Related Links
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Related Info
Other Identifiers
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Studio RER
Identifier Type: -
Identifier Source: org_study_id
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