This pilot trial studies the best dose and how well dronabinol (Syndros or Marinol) works in improving pain and decreasing opioid requirement in patients with breast cancer that has spread to the bones. Dronabinol (Syndros or Marinol) acts directly on the appetite and vomiting control centers in the brain to stimulate appetite and prevent vomiting. In addition, this agent induces analgesia. Giving dronabinol and opioid may relieve bone pain and decrease the need for opioid use in patients with breast cancer bone metastasis.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03661892.
PRIMARY OBJECTIVE:
I. To evaluate change in opiate pain medication use after addition of dronabinol (Syndros or Marinol) for 8 weeks.
SECONDARY OBJECTIVES:
I. To evaluate change in pain using the Brief Pain Inventory tool.
II. To evaluate change in quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-Core (C)30 version 3.0 questionnaire.
III. To evaluate change in bone modulation by dronabinol (Syndros or Marinol).
OUTLINE: This is a dose-escalation study of dronabinol.
Patients receive dronabinol orally (PO) twice daily (BID) for 8 weeks in the absence of disease progression or unacceptable toxicity.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorPavani Chalasani
