Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys

NCT06777004 | Completed

• 1 other identifier: CIBP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Pain

Keywords

bone metastasis

Outcome Measures

Primary Outcomes (1)

• Identify what are the possible factors associated with a faster achievement of stable pain.

  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)

  From enrollment to 21 days following the start of analgesic treatment

Secondary Outcomes (1)

• To evaluate the incidence of neuropathic pain associated with bone metastases and its influence on the anxiety domain, quality of life, and patient autonomy.

  From enrollment to 21 days following the start of analgesic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who arrive within 24 months starting from February 2022 will be enrolled to the observation of one of the Centers participating in the study. A total population of about 200 patients is expected, a number based on an estimate retrospective on patients belonging to our Center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Irccs Azienda Ospedaliero Universitario Di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara Lenzi, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: February 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)