This is a feasibility study to assess the use of a Digital Medicine Program (consisting
of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5
mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with
metastatic disease experiencing uncontrolled pain.
Additional locations may be listed on ClinicalTrials.gov for NCT04194528.
See trial information on ClinicalTrials.gov for a list of participating sites.
Given the high prevalence of cancer pain and issues with undertreatment and opioid
misuse, focused efforts to improve monitoring of medication ingestion patterns are
needed. This study will test the feasibility of using a Digital Medicine Program
(consisting of an FDA-approved ingestible sensor co-encapsulated with
oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application)
in cancer patients with metastatic disease experiencing uncontrolled pain. Data collected
from this study (such as information on patterns of DMP usage by patients and physicians
and changes to medication dosage based on the reported symptoms) will inform the design
of a randomized controlled trial of the DMP vs. usual care to control cancer pain and
increase quality of life. If successful, this DMP could be a new way for physicians to
evaluate patients' pain medication use patterns and titrate for adequate pain control
while concurrently monitoring for adverse effects or abusive/addictive behavior. It will
also promote improved communication between patients and their physicians and potentially
address and ease some of patients' concerns and hesitancies regarding opioid medications.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationSWOG Cancer Research Network
