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

Neuropathic Pain Clinical Trial

— RER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946555
• Other study ID #: Studio RER
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: April 13, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines AgencyItaly: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Cancer Pain
• Breakthrough Pain
• Cancer Pain
• Neuralgia
• Neuropathic Pain
• Tumor

Intervention

Drug:
• Morphine

• Fentanyl

• Methadone

• Buprenorphine

• Oxycodone

• Hydromorphone

• Tapentadol

Locations

Country	Name	City	State
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	AO Universitaria Policlinico di Modena	Modena	Italia
Italy	A.O. Universitaria Parma	Parma	Italia
Italy	Ospedale di Piacenza	Piacenza
Italy	Arcispedale S. Maria Nuova Azienda Ospedaliera	Reggio Emilia
Italy	Ospedale degli Infermi	Rimini
Italy	Ospedale Magati	Scandiano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and duration of episodes of BTcP		28 days	No
Primary	Time to reach the peak of pain in the BTcP		28 days	No
Primary	Maximum intensity of BTcP		28 days	No
Secondary	Intensity of pain	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;	28 days	No
Secondary	Effect of the treatments	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	28 days	No

External Links

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