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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01946555
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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.

Condition or disease Intervention/treatment
Tumor Cancer Pain Breakthrough Cancer Pain Neuropathic Pain Drug: Morphine Drug: Fentanyl Drug: Methadone Drug: Buprenorphine Drug: Oxycodone Drug: Hydromorphone Drug: Tapentadol

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
Study Start Date : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Number and duration of episodes of BTcP [ Time Frame: 28 days ]
  2. Time to reach the peak of pain in the BTcP [ Time Frame: 28 days ]
  3. Maximum intensity of BTcP [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Intensity of pain [ Time Frame: 28 days ]
    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;

  2. Effect of the treatments [ Time Frame: 28 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01946555

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AO Universitaria Policlinico di Modena
Modena, Italia, Italy, 41124
A.O. Universitaria Parma
Parma, Italia, Italy
Ospedale Magati
Scandiano, Italia, 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
Meldola, Italy
Ospedale di Piacenza
Piacenza, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera
Reggio Emilia, Italy
Ospedale degli Infermi
Rimini, Italy
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
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Principal Investigator: Oscar Corli, MD Mario Negri Institute of Pharmacological Research - IRCCS
Additional Information:
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Responsible Party: Mario Negri Institute for Pharmacological Research Identifier: NCT01946555    
Other Study ID Numbers: Studio RER
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Mario Negri Institute for Pharmacological Research:
Breakthrough cancer pain
Neuropathic pain
Major opioid
Additional relevant MeSH terms:
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Cancer Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors