Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-01 @ 5:23 PM
Study NCT ID:
NCT03661892
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2018-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-04
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:
None
Brief Summary:
In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.
Detailed Description:
This a prospective single arm study enrolling patients with bone metastases from breast cancer who have been on opioid therapy for bone pain for at least 4 weeks. All patients start on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study period (total of 8wks). For patients who have side effects secondary to Sydnros, the dose will be decreased. Side effect assessment will be done by the research team 2 days after making the dose adjustment. If subject continues to have side effects, dose will be held until resolution of symptoms. If the study medicine is held for more than a week continuously, they will be taken off the study. In addition, they will have baseline blood and urine collected for biomarkers and also complete study related questionnaires (for secondary end points). They are also provided an opioid drug diary which they will take home during visit 1 to record their opioid pain medication use. Research staff will be calling patients on a weekly basis to reinforce opioid drug diary, assess for Syndros side effect, and adjust dose of Syndros. At the end of 8 weeks blood and urine is collected again and they will complete the study questionnaires.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-01916 | REGISTRY | NCI Trial Identifier | View |