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

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

Detailed Description
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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.

Official Title
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Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer

Conditions
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Bone Metastases, Breast Cancer, Pain

Intervention / Treatment
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* Drug: Syndros


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This a prospective single arm study enrolling patients (n=20) with bone metastases form breast cancer who have been on opioid therapy for bone pain for at least 4 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Syndros)<br>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). | Drug: Syndros<br>* As noted in arm description. For patients who have side effects secondary to Sydnros, the dose will be decreased as below: Dose subject is taking Reduction recommendation 8.4mg BID Decreased to 8.4mg AM , 4.2mg PM (or it can be 4.2g in AM and 8.4mg in PM- depending on their side effect timing) 8.4mg AM, 4.2mg PM (or vice versa) 4.2mg BID 4.2mg BID 4.2mg once a day 4.2mg once a day Stop and take off study<br>* Other names: Dronabinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for opiate pain medication | To evaluate change in opiate pain medication use after addition of Syndros.Hypothesis: Syndros will decrease the opiate usage by at least 20% at the end of 8wks. We will evaluate opioid pain medication use by using a drug diary and assessing the percentage change in opiate pain medication requirement at end of 8wks. | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | To evaluate change in pain using the Brief Pain Inventory tool. Hypothesis: Addition of Syndros will decrease pain intensity on the rating tool. | Eight weeks | 
| Change in quality of life | 2. To evaluate change in quality of life using the EORTC QLQ-C30 version 3.0 questionnaire. Hypothesis: Addition of Syndros will improve quality of life. | Eight weeks | 
| Change in bone modulation | To evaluate change in bone modulation by Syndros. Hypothesis: Syndros will decrease bone degradation there by decreasing serum and urine C-terminal telopeptide collagen cross-linker (CTX), N-terminal telopeptide (NTX) and increase osteocalcin. | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Bone Metastases, Pain, Opioid, Syndros, Bone pain