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

Information source: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tumor; Cancer Pain; Breakthrough Cancer Pain; Neuropathic Pain

Intervention: Morphine (Drug); Fentanyl (Drug); Methadone (Drug); Buprenorphine (Drug); Oxycodone (Drug); Hydromorphone (Drug); Tapentadol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Mario Negri Institute for Pharmacological Research

Official(s) and/or principal investigator(s):
Oscar Corli, MD, Principal Investigator, Affiliation: Mario Negri Institute of Pharmacological Research - IRCCS

Overall contact:
Oscar Corli, MD, Email: oscar.corli@marionegri.it

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number and duration of episodes of BTcP

Time to reach the peak of pain in the BTcP

Maximum intensity of BTcP

Secondary outcome:

Intensity of pain

Effect of the treatments

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Oscar Corli, MD, Email: oscar.corli@marionegri.it

Azienda USL - Ospedale di Carpi e Mirandola, Carpi, Italy; Recruiting
Elena Bandieri, MD, Sub-Investigator

A.O.U. Arcispedale S. Anna, Ferrara, Italy; Recruiting
Antonio Frassoldati, MD, Sub-Investigator
Antonio Cuneo, MD, Sub-Investigator

Ospedale di Fiorenzuola D'Arda, Fiorenzuola D'Arda, Italy; Recruiting
Giuseppe Civardi, MD, Sub-Investigator

Ospedale di Lugo, Lugo, Italy; Recruiting
Luigi Montanari, MD, Sub-Investigator

IRCCS-IRST Forlì, Meldola, Italy; Recruiting
Marco Maltoni, MD, Sub-Investigator

Ospedale di Piacenza, Piacenza, Italy; Recruiting
Luigi Cavanna, MD, Sub-Investigator
Daniele Vallisa, MD, Sub-Investigator

Arcispedale S. Maria Nuova Azienda Ospedaliera, Reggio Emilia, Italy; Recruiting
Corrado Boni, MD, Sub-Investigator
Nunziata D'Abbiero, MD, Sub-Investigator
Angela Ferrari, MD, Sub-Investigator

Ospedale degli Infermi, Rimini, Italy; Recruiting
Davide Tassinari, MD, Sub-Investigator

AO Universitaria Policlinico di Modena, Modena, Italia 41124, Italy; Recruiting
Mario Luppi, MD, Sub-Investigator

A.O. Universitaria Parma, Parma, Italia, Italy; Recruiting
Franco Aversa, MD, Sub-Investigator

Ospedale Magati, Scandiano, Italia, Italy; Recruiting
Luca Cottafavi, MD, Sub-Investigator

Additional Information

Related publications:

Portenoy RK, Hagen NA. Breakthrough pain: definition and management. Oncology (Williston Park). 1989 Aug;3(8 Suppl):25-9. Review.

Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990 Jun;41(3):273-81.

Davies AN. Cancer-related breakthrough pain. Br J Hosp Med (Lond). 2006 Aug;67(8):414-6. Review.

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.

Starting date: September 2013
Last updated: June 9, 2015

Page last updated: August 23, 2015

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