Irccs Azienda Ospedaliero Universitario Di Bologna
Bologna, 40138, Italy
NCT Number: NCT06777004
The study aims to improve the knowledge of pain associated with bone metastases, in particular to analyze the clinical course of patients who are affected by pain due to bone metastases, in order to better understand which factors may be related to a faster response to pain therapy.
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Notify Me18 year and older
All sexes
Observational
Bologna, 40138, Italy
This is a non-profit, non-pharmacological, multicenter prospective observational study. Enrollment will last for 24 months from the opening of the study.
The overall duration of the study will be 36 months.
Based on the primary endpoint, patients will be stratified into 5 groups, corresponding to different times of achievement of stable pain:
Enrolled patients will undergo validated tests, administered by appropriately trained personnel. All the tests mentioned here are in use in clinical practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Obtaining informed consent; age greater than or equal to 18 years definite diagnosis of solid tumor (histological and/or radiological, as indicated by the corresponding guidelines), already in charge of an Oncology service. bone metastases at any site, regardless of the type of primary tumor; patient with pain related to established, new-onset, or current bone metastases of the recrudescence of painful symptoms Enrollment must occur at the time of requesting medical intervention for pain related to bone lesions, within 72 hours of reporting.
Exclusion criteria
patients with cognitive and/or conscious impairments that could affect the evaluation; Patients with a history of substance/alcohol abuse/dependence or conditions that contraindicate administration of opioid analgesics; presence of non-oncological pathologies in the decompensation phase. non-understanding of the Italian language, both spoken and written.
Time frame: From enrollment to 21 days following the start of analgesic treatment
Specifically, the presence of a possible association between the analgesic response and factors related to the patient (clinical, demographic and laboratory), the neoplasm, the characteristics of symptomatic bone lesions and the results of the tests administered to the patient at enrollment and at the end-of-study visit will be sought.
Primary end-point: addition of stable pain (NRS never greater than 3/10, for three consecutive days, with less than 3 intakes of analgesic therapy as needed (rescue dose) on each of these three days)
Time frame: From enrollment to 21 days following the start of analgesic treatment
Incidence of neuropathic pain, defined based on the LANSS screening test and NeuPSIG guideline diagnostic algorithm.
Whether or not PPG (personalized pain goal) is met
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys: a Multicenter Prospective Observational Study
Acronym: CIBP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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