Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain | RxWiki

Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain

Overview[ - collapse ][ - ]

Purpose	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	Tumor Cancer Pain Breakthrough Cancer Pain Neuropathic Pain
Intervention	Drug: Morphine Drug: Fentanyl Drug: Methadone Drug: Buprenorphine Drug: Oxycodone Drug: Hydromorphone Drug: Tapentadol
Phase	N/A
Sponsor	Mario Negri Institute for Pharmacological Research
Responsible Party	Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier	NCT01946555
First Received	September 10, 2013
Last Updated	November 18, 2013
Last verified	September 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 10, 2013
Last Updated Date	November 18, 2013
Start Date	September 2013
Estimated Primary Completion Date	December 2014
Current Primary Outcome Measures	Number and duration of episodes of BTcP [Time Frame: 28 days] [Designated as safety issue: No] Time to reach the peak of pain in the BTcP [Time Frame: 28 days] [Designated as safety issue: No] Maximum intensity of BTcP [Time Frame: 28 days] [Designated as safety issue: No]
Current Secondary Outcome Measures	Intensity of pain [Time Frame: 28 days] [Designated as safety issue: No]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] [Designated as safety issue: No]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

Descriptive Information[ + expand ][ + ]

Brief Title	Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Official Title	Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Observational
Study Phase	N/A
Study Design	Observational Model: Cohort, Time Perspective: Prospective
Condition	Tumor Cancer Pain Breakthrough Cancer Pain Neuropathic Pain
Intervention	Drug: Morphine Drug: Fentanyl Drug: Methadone Drug: Buprenorphine Drug: Oxycodone Drug: Hydromorphone Drug: Tapentadol
Study Arm (s)	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).

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	250
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2014
Eligibility Criteria	Inclusion Criteria: - diagnosis (histologic or cytologic) of locally advanced cancer and / or metastatic disease; - 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: - participation in other research projects that are in conflict or could confound the results of the study; - 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Oscar Corli, MD oscar.corli@marionegri.it
Location Countries	Italy

Administrative Information[ + expand ][ + ]

NCT Number	NCT01946555
Other Study ID Numbers	Studio RER
Has Data Monitoring Committee	No
Information Provided By	Mario Negri Institute for Pharmacological Research
Study Sponsor	Mario Negri Institute for Pharmacological Research
Collaborators	Not Provided
Investigators	Principal Investigator: Oscar Corli, MD Mario Negri Institute of Pharmacological Research - IRCCS
Verification Date	September 2013

Locations[ + expand ][ + ]

AO Universitaria Policlinico di Modena	Modena, Italia, Italy, 41124 Sub-Investigator: Mario Luppi, MD Recruiting
A.O. Universitaria Parma	Parma, Italia, Italy Sub-Investigator: Franco Aversa, MD Recruiting
Ospedale Magati	Scandiano, Italia, Italy Sub-Investigator: Luca Cottafavi, MD Recruiting
Azienda USL - Ospedale di Carpi e Mirandola	Carpi, Italy Sub-Investigator: Elena Bandieri, MD Recruiting
A.O.U. Arcispedale S. Anna	Ferrara, Italy Sub-Investigator: Antonio Frassoldati, MD Recruiting
Ospedale di Fiorenzuola D'Arda	Fiorenzuola D'Arda, Italy Sub-Investigator: Giuseppe Civardi, MD Recruiting
Ospedale di Lugo	Lugo, Italy Sub-Investigator: Luigi Montanari, MD Recruiting
IRCCS-IRST Forlì	Meldola, Italy Sub-Investigator: Marco Maltoni, MD Recruiting
Ospedale di Piacenza	Piacenza, Italy Sub-Investigator: Luigi Cavanna, MD Recruiting
Arcispedale S. Maria Nuova Azienda Ospedaliera	Reggio Emilia, Italy Sub-Investigator: Corrado Boni, MD Recruiting
Ospedale degli Infermi	Rimini, Italy Sub-Investigator: Davide Tassinari, MD Recruiting