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

Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys: a Multicenter Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Cancer Pain

Detailed Description

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:

1. patients who achieve stable pain at the first assessment (3 days)
2. patients who achieve stable pain at the second or third assessment (6-9 days)
3. patients who achieve stable pain at the fourth or fifth assessment (12-15 days)
4. patients who achieve stable pain at the sixth or seventh assessment (18-21 days)
5. patients who do not reach stable pain on the twenty-first day Based on the secondary endpoints, patients with and without neuropathic pain and with and without reaching PPG will be compared with the results of the HADS, EORT-QLQ-C30 [11] and Karnofsky scale [12-13] tests, in terms of final MEDD (morphine equivalent daily opioid dose) and type of drugs taken.

Enrolled patients will undergo validated tests, administered by appropriately trained personnel. All the tests mentioned here are in use in clinical practice.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Irccs Azienda Ospedaliero Universitario Di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the incidence of neuropathic pain associated with bone metastases and its influence on the anxiety domain, quality of life, and patient autonomy.	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	From enrollment to 21 days following the start of analgesic treatment

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Barbara Lenzi, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: bone metastasis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: CIBP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No