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

NCT01946555 | Completed

• 1 other identifier: Studio RER
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 11

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.

Conditions

Tumor; Cancer Pain; Breakthrough Cancer Pain; Neuropathic Pain

Keywords

Breakthrough cancer pain; Neuropathic pain; Major opioid; Analgesics

Outcome Measures

Primary Outcomes (3)

• Number and duration of episodes of BTcP

  28 days

• Time to reach the peak of pain in the BTcP

  28 days

• Maximum intensity of BTcP

  28 days

Secondary Outcomes (2)

• Intensity of pain

  28 days

• Effect of the treatments

  28 days

Study Arms (1)

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).

Drug: Morphine; Drug: Fentanyl; Drug: Methadone; Drug: Buprenorphine; Drug: Oxycodone; Drug: Hydromorphone; Drug: Tapentadol

Interventions

Morphine DRUG

Worst pain, Average pain

Fentanyl DRUG

Worst pain, Average pain

Methadone DRUG

Worst pain, Average pain

Buprenorphine DRUG

Worst pain, Average pain

Oxycodone DRUG

Worst pain, Average pain

Hydromorphone DRUG

Worst pain, Average pain

Tapentadol DRUG

Worst pain, Average pain

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (11)

AO Universitaria Policlinico di Modena

Modena, Italia, 41124, Italy

Location

A.O. Universitaria Parma

Parma, Italia, Italy

Location

Ospedale Magati

Scandiano, Italia, Italy

Location

Azienda USL - Ospedale di Carpi e Mirandola

Carpi, Italy

Location

A.O.U. Arcispedale S. Anna

Ferrara, Italy

Location

Ospedale di Fiorenzuola D'Arda

Fiorenzuola d'Arda, Italy

Location

Ospedale di Lugo

Lugo, Italy

Location

IRCCS-IRST Forlì

Meldola, Italy

Location

Ospedale di Piacenza

Piacenza, Italy

Location

Arcispedale S. Maria Nuova Azienda Ospedaliera

Reggio Emilia, Italy

Location

Ospedale degli Infermi

Rimini, Italy

Location

Related Publications (5)

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

  PMID: 2484297 BACKGROUND

• 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.

  PMID: 1697056 BACKGROUND

• 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.

  PMID: 16918095 BACKGROUND

• 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.

  PMID: 20842024 BACKGROUND

• 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.

  PMID: 23796584 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms; Cancer Pain; Neuralgia

Interventions

Morphine; Fentanyl; Methadone; Buprenorphine; Oxycodone; Hydromorphone; Tapentadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Ketones; Organic Chemicals; Codeine; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Oscar Corli, MD

  Mario Negri Institute of Pharmacological Research - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

IT (11)