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

University of Arizona

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer; Pain; Bone Metastases

Treatments: Drug: Syndros

Study type: Interventional

Funder types: Other

Identifiers

NCT03661892

1808852902

NCI-2018-01916 (Registry Identifier)

Details and patient eligibility

About

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

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.

Enrollment: 14 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Treatment (Syndros)

Experimental group

Description:

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).

Treatment:

Drug: Syndros