Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
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|ClinicalTrials.gov Identifier: NCT03661892|
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases Breast Cancer Pain||Drug: Syndros||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer|
|Actual Study Start Date :||December 19, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Treatment (Syndros)
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).
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
Other Name: Dronabinol
- Need for opiate pain medication [ Time Frame: Eight weeks ]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.
- Change in pain [ Time Frame: Eight weeks ]To evaluate change in pain using the Brief Pain Inventory tool. Hypothesis: Addition of Syndros will decrease pain intensity on the rating tool.
- Change in quality of life [ Time Frame: Eight weeks ]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.
- Change in bone modulation [ Time Frame: Eight weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661892
|Contact: Pavani Chalasani, MD||(520) email@example.com|
|Contact: Amy Selegue, BA, BSN, RN||(520) firstname.lastname@example.org|
|United States, Arizona|
|University of Arizona||Recruiting|
|Tucson, Arizona, United States, 85742|
|Contact: Dana Lewallen 520-626-2175|
|Principal Investigator: Pavani Chalasani|
|Principal Investigator:||Pavani Chalasani, MD||University of Arizona|