Clinical trial · Interventional
Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets
Title A Pilot Trial to Evaluate Syndros in Decreasing Opioid Requirement in Patients With Bone Metastases From Breast Cancer
NCT03661892CI-TRIAL-00051532completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Syndros | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Syndros)
- 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).
- interventionNames
- Drug: Syndros
Primary outcomes (1)
- measure
- Need for opiate pain medication
- timeFrame
- Eight weeks
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSegar J, Farr K, Junak M, Roe D, Ehsani S, Ibrahim M, Vanderah TW, Chalasani P. Evaluation of dronabinol to decrease opioid use for cancer-induced bone pain. Oncologist. 2026 Jul 8;31(8):oyag163. doi: 10.1093/oncolo/oyag163. PMID 42050177