Clinical trial NCT01946555: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor
Cancer Pain
Breakthrough Cancer Pain
Neuropathic Pain
Keywords: Breakthrough cancer pain
Neuropathic pain
Major opioid
Analgesics
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves a longitudinal evaluation of BTCP in cancer patients with pain, through a follow-up of 4 weeks, which will examine in a dynamic clinical aspects (variation over time of the number and duration of episodes, painful intensity, changes in ATC and rescue therapy).

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.


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.

Primary outcomes:
measure: Number and duration of episodes of BTcP
timeFrame: 28 days
measure: Time to reach the peak of pain in the BTcP
timeFrame: 28 days
measure: Maximum intensity of BTcP
timeFrame: 28 days
Secondary outcomes:
measure: Intensity of pain
timeFrame: 28 days
measure: Effect of the treatments
timeFrame: 28 days
Other outcomes:
Locations:
city: Modena
country: Italy
facility: AO Universitaria Policlinico di Modena
state: Italia
city: Parma
country: Italy
facility: A.O. Universitaria Parma
state: Italia
city: Scandiano
country: Italy
facility: Ospedale Magati
state: Italia
city: Carpi
country: Italy
facility: Azienda USL - Ospedale di Carpi e Mirandola
city: Ferrara
country: Italy
facility: A.O.U. Arcispedale S. Anna
city: Fiorenzuola D'Arda
country: Italy
facility: Ospedale di Fiorenzuola D'Arda
city: Lugo
country: Italy
facility: Ospedale di Lugo
city: Meldola
country: Italy
facility: IRCCS-IRST Forlì
city: Piacenza
country: Italy
facility: Ospedale di Piacenza
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova Azienda Ospedaliera
city: Rimini
country: Italy
facility: Ospedale degli Infermi
Study officials:
affiliation: Mario Negri Institute of Pharmacological Research - IRCCS
name: Oscar Corli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Portenoy RK, Hagen NA. Breakthrough pain: definition and management. Oncology (Williston Park). 1989 Aug;3(8 Suppl):25-9.
citation: 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.
citation: 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.
citation: 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.
citation: 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.