Breast Cancer Clinical Trial

Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

Summary

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
Be capable of signing and providing written consent in accordance with institutional and federal guidelines
Have metastatic breast cancer with bone metastases
Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
Age ≥ 21 years
Must be on opioid therapy for bone pain for at least 4 weeks

Exclusion Criteria:

Have a known sensitivity to dronabinol or alcohol
Have a history of hypersensitivity reaction to alcohol
Using medical marijuana currently
Using Syndros for nausea or appetite stimulant
Receiving or have received disulfiram- or metronidazole- containing products within past 14 days
Are currently pregnant or are of child-bearing age and refuse to use adequate contraception
Have a history of psychiatric illness
Have a history of seizure disorders

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

14

Study ID:

NCT03661892

Recruitment Status:

Completed

Sponsor:

University of Arizona

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There is 1 Location for this study

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University of Arizona
Tucson Arizona, 85742, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

14

Study ID:

NCT03661892

Recruitment Status:

Completed

Sponsor:


University of Arizona

How clear is this clinincal trial information?

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