Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT06777004
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2025-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
Study Overview
Official Title:
Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys: a Multicenter Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIBP
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: