Cancer PainCIBPNCT06777004
Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys
An observational study of Cancer Pain, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- patients who achieve stable pain at the first assessment (3 days)
- patients who achieve stable pain at the second or third assessment (6-9 days)
- patients who achieve stable pain at the fourth or fifth assessment (12-15 days)
- patients who achieve stable pain at the sixth or seventh assessment (18-21 days)
- 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.
- Conditions
- Cancer Pain
- Keywords
- bone metastasis
- Medical subject headings
- Cancer Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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
Measured: From enrollment to 21 days following the start of analgesic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2022
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Lenzi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777004
- Sponsor's protocol ID
- CIBP
- Acronym
- CIBP
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Analgesic Response in Patients With Pain Associated With Bone Metastasys: a Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06777004
- Acronym / sponsor ID
- CIBP / CIBP
- Conditions
- Cancer Pain
- Keywords
- bone metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- patients who achieve stable pain at the first assessment (3 days)
- patients who achieve stable pain at the second or third assessment (6-9 days)
- patients who achieve stable pain at the fourth or fifth assessment (12-15 days)
- patients who achieve stable pain at the sixth or seventh assessment (18-21 days)
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify what are the possible factors associated with a faster achievement of stable pain.
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)
1 secondary outcome
To evaluate the incidence of neuropathic pain associated with bone metastases and its influence on the anxiety domain, quality of life, and patient autonomy.
Time frame: From enrollment to 21 days following the start of analgesic treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Lenzi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify what are the possible factors associated with a faster achievement of stable pain. (time frame: From enrollment to 21 days following the start of analgesic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.