Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Number and duration of episodes of BTcP
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Morphine (Drug)
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).
干预措施: Fentanyl (Drug)
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).
干预措施: Methadone (Drug)
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).
干预措施: Buprenorphine (Drug)
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).
干预措施: Oxycodone (Drug)
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).
干预措施: Hydromorphone (Drug)
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).
干预措施: Tapentadol (Drug)
结局指标
主要结局
Number and duration of episodes of BTcP
时间窗: 28 days
Time to reach the peak of pain in the BTcP
时间窗: 28 days
Maximum intensity of BTcP
时间窗: 28 days
次要结局
- Intensity of pain(28 days)
- Effect of the treatments(28 days)