This phase IV trial studies the safety, side effects, and best doses of buprenorphine when used with other opioid pain medications in treating patients with cancer-related pain. Buprenorphine is a partial opioid that may help relieve cancer-related pain caused by opioid pain medications, such as morphine. Learning about side effects of opioids in patients with cancer-related pain may help plan treatment and may help patients live more comfortably. This study may help researcher find out if buprenorphine when used with other pain medication to treat cancer causes withdrawal symptoms such as nausea and vomiting, diarrhea, chills and muscle or bone pain.
Additional locations may be listed on ClinicalTrials.gov for NCT05910190.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Fox Chase Cancer CenterStatus: Active
Contact: Marcin Chwistek
Phone: 215-728-3544
PRIMARY OBJECTIVES:
I. To determine dose ranges of full agonist opioids (FAO) and buprenorphine when used concomitantly. (Retrospective study)
II. To determine presence or absence of withdrawal symptoms on concomitant buprenorphine and FAO therapy based on medical record review and/or consultation with Supportive Oncology & Palliative Care Program (SOPCP) providers who follow the patient in question. (Retrospective study)
III. To determine the presence of withdrawal symptoms by Clinical Opioid Withdrawal Scale (COWS) score > 13 in the setting of clinically appropriate dose escalation of buprenorphine and FAO. (Prospective study)
SECONDARY OBJECTIVES:
1. To determine maximum dose of FAO and associated dose of buprenorphine at that time and maximum dose of buprenorphine with associated FAO. (Prospective study)
2. Assess usage and acceptability of the Continuous Precision Medicine (CPM) prescription (Rx) application (app) to monitor medication usage over three months. (Prospective study)
OUTLINE:
RETROSPECTIVE STUDY: Patients medical records are reviewed.
PROSPECTIVE STUDY: Patients receive buprenorphine orally (PO) and opioids on study. Patients also use CPM Rx mobile application to report pain level.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorMarcin Chwistek