Overview

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

Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Treatments:
Analgesics, Opioid
Buprenorphine
Fentanyl
Hydromorphone
Methadone
Morphine
Oxycodone
Tapentadol
Criteria
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.