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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tumor, Cancer Pain, Breakthrough Cancer Pain, Neuropathic Pain

Intervention / Treatment
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* Drug: Morphine
* Drug: Fentanyl
* Drug: Methadone
* Drug: Buprenorphine
* Drug: Oxycodone
* Drug: Hydromorphone
* Drug: Tapentadol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Worst pain, Average pain<br>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<br> <br> Drug: Fentanyl<br> <br> Drug: Methadone<br> <br> Drug: Buprenorphine<br> <br> Drug: Oxycodone<br> <br> Drug: Hydromorphone<br> <br> Drug: Tapentadol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breakthrough cancer pain, Neuropathic pain, Major opioid, Analgesics