Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain (RER)
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|ClinicalTrials.gov Identifier: NCT01946555|
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : April 14, 2016
The BTP (Breakthrough pain)was defined as "a transient exacerbation of pain that occurs either spontaneously, or in relation to a specific predictable or unpredictable trigger, despite relatively stable and adequately controlled background pain".
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.
|Condition or disease||Intervention/treatment|
|Tumor Cancer Pain Breakthrough Cancer Pain Neuropathic Pain||Drug: Morphine Drug: Fentanyl Drug: Methadone Drug: Buprenorphine Drug: Oxycodone Drug: Hydromorphone Drug: Tapentadol|
|Study Type :||Observational|
|Actual Enrollment :||150 participants|
|Official Title:||Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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).
- Number and duration of episodes of BTcP [ Time Frame: 28 days ]
- Time to reach the peak of pain in the BTcP [ Time Frame: 28 days ]
- Maximum intensity of BTcP [ Time Frame: 28 days ]
- Intensity of pain [ Time Frame: 28 days ]Evaluate the relationship between the intensity of baseline pain in its various dimensions (worst, average and light on the last 24 hours) and intensity of pain reported during episodes of BTCP;
- Effect of the treatments [ Time Frame: 28 days ]Evaluate over time the effect of the treatments on the rescue BTCP, in terms of reduction of the number that the intensity of the episodes of BTCP
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946555
|AO Universitaria Policlinico di Modena|
|Modena, Italia, Italy, 41124|
|A.O. Universitaria Parma|
|Parma, Italia, Italy|
|Scandiano, Italia, Italy|
|Azienda USL - Ospedale di Carpi e Mirandola|
|A.O.U. Arcispedale S. Anna|
|Ospedale di Fiorenzuola D'Arda|
|Fiorenzuola D'Arda, Italy|
|Ospedale di Lugo|
|Ospedale di Piacenza|
|Arcispedale S. Maria Nuova Azienda Ospedaliera|
|Reggio Emilia, Italy|
|Ospedale degli Infermi|
|Principal Investigator:||Oscar Corli, MD||Mario Negri Institute of Pharmacological Research - IRCCS|