A Study to Collect Data About Analgesia in Patients With Bone Metastasis

An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02774213

Enrollment

Registered

2016-05-17

Start date

2014-07-31

Completion date

2017-04-28

Last updated

2019-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastasis

Brief summary

Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.

Interventions

OTHERQuestionnaires completion

OTHERClinical Pain Assessments

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with bone tumors or bone metastasis from any primary cancer origin that is supported by histological or radiological investigations. * Patients having been or being treated for their bone metastasis and/or their primary cancer. * Patients who require analgesic treatment for unsatisfactory pain relief. * Patients will be required to score at least 4 on the WAPS 11-point NRS during the week preceding enrollment. * Patients undergoing or not a radiotherapy program provided visit procedures are performed before any radiotherapy sessions if scheduled on the same visit days. * Are men or women of at least 18 years of age. * Are reliable and willing to make themselves available for the entire duration of the study and are willing to follow study procedures. * Have given written informed consent approved by the relevant Ethics Committee governing the study site.

Exclusion criteria

* Patients having had a major surgery within 28 days prior to signing Informed Consent Document or planning to have a major surgery during the study. * Patients having a life expectancy \< 3 months according to Investigator judgment. * Patients having poor nutritional status or whose condition is unstable or who could be rapidly deteriorating in such a way that they would not be able to complete the study. * Patients with a current or recent history unrelated to their cancer condition, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the study. * Patients having a Karnofsky performance status below 70% or WHO score (Eastern Cooperative Oncology Group (ECOG)/Zubrod score) above 1. * Are Investigator site staffs directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. * Any other relevant medical disorder likely to interfere with the trial or represent a risk for the patient. * Patients under legal protection, according to the country law. * Patients currently enrolled in a clinical trial involving use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or in an exclusion period according to the national law.

Design outcomes

Primary

Measure	Time frame	Description
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)	Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)	11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)

Secondary

Measure	Time frame	Description
Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	The pain severity score of BPI is an arithmetic average of the 4 severity scores reported on an 11- point NRS going from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI severity questions are: 3\. Your pain at its worst in the last 24 hours? 4. Your pain at its least in the last 24 hours? 5. Your pain on the average? 6. How much pain you have right now?
Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst
Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was was the mean of the WPS of the first 7 days after first visit (Visit 1); end of study measure was the mean of the WPS of the last 7 days prior to last visit (Visit 2)
Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	Pain scale of the Quality-of-Life Questionnaire in 30 questions (QLQ-C30); 2 items in the Pain scale ranging each from 1 to 4 (high score for a symptom scale / item represents a high level of symptomatology / problems); Pain score is sum of of the 2 items
Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	The pain interference score of BPI is an arithmetic average of the 7 interference scores reported on an 11-point NRS going from 0 (does not interfere) to 10 (completely interferes) The BPI interference questions are: 9\. Pain has interfered in the last 24 hours with 1. General Activity? 2. Mood? 3. Walking Abililty? 4. Work? 5. Relations with other people? 6. Sleep? 7. Enjoyment of life?
Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)	Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)	Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.

Countries

Belgium, France

Participant flow

Participants by arm

Arm	Count
Cancer-Induced Bone Pain (CIBP) Cancer patients with bone metastasis suffering from pain	74
Total	74

Baseline characteristics

Characteristic	Cancer-Induced Bone Pain (CIBP)	—
Age, Continuous	60.1 years	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	42 Participants	—
Sex: Female, Male Male	11 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)

11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)

Time frame: Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)

Population: Only the patients completing the study per protocol were analyzed. APS was available for 47 patients amongst the per protocol completers.

Arm	Measure	Value (MEAN)	Dispersion
Cancer-Induced Bone Pain (CIBP)	Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)	2.26 units on a scale	Standard Deviation 2.95

Secondary

Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)

Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst