Clinical trial NCT03661892: Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
Official title: Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bone Metastases
Breast Cancer
Pain
Keywords: Breast Cancer
Bone Metastases
Pain
Opioid
Syndros
Bone pain
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Need for opiate pain medication
timeFrame: Eight weeks
Secondary outcomes:
measure: Change in pain
timeFrame: Eight weeks
measure: Change in quality of life
timeFrame: Eight weeks
measure: Change in bone modulation
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Pavani Chalasani, MD
role: PRINCIPAL_INVESTIGATOR
References: