Clinical trial · Interventional
Evaluation of ReX-C® System for Medication Adherence in Oncology Patients Taking Oral Oncolytics
Clinical Study to Evaluate the Safety, Usability and Efficacy of the ReX-C® System in Measurement and Management of Medication Adherence and Clinical Self-reporting, in Oncology Patients Receiving Home-based Oral Oncolytic Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Awaiting next model of the device
Summary
Brief summary (as posted)
In recent decades, an increasing number of oral anticancer medications (oral oncolytics) have been approved. Oral oncolytics now make up to 30% of the oncology market, and their use is continually expanding. Oral oncolytics can be a significant benefit for patients and providers. Patients who receive them often report a greater sense of control over their treatment, less interference with daily work and social activities, reduced travel time and costs, and the elimination of discomfort associated with an IV line. In rural areas, the oral route is crucial because the closest treatment center may be hours away and weather may complicate travel. Moreover, oral therapy is less invasive and reduces nursing time in infusion suites and risks to patients. However, making cancer treatments available in oral form transfers most of the responsibility for correct administration of the drug to the patient. The more complex the oral treatment regimen, the higher the risk of errors and non-adherence. Oral Oncolytics are high-risk and high cost drugs. Hence, with this transfer of responsibility comes the need to support patients in their adherence to the directed regimen and to effectively monitor them at home.
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 |
|---|---|---|---|
| Adherence, Medication | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ReX-C system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ReX-C intervention
- description
- Subjects use ReX-C to receive oral oncolytic medications. Adherence data, side effects and response to treatment are monitored online in real time via ReX-C cloud.
- interventionNames
- Device: ReX-C system
Primary outcomes (4)
- measure
- Number of safety events during administration of oral oncolytic medications by ReX-C
- timeFrame
- 8 weeks
- description
- Safety events include: pill overdose, pill inhalation during pill ingestion, pill malformation upon dispensing and any severe adverse events related to pill intake by the ReX-C device.
- measure
- Rate of subjects feel comfortable to use ReX-C for pill intake and side effects report
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or Female, at least 18 years of age 2. Subject is able to swallow pills and during training successfully achieves 2 administrations of "demo" pills (Tic-Tac mints) by the ReX-C. 3. Subject is able to read and understand the Informed Consent Form. 4. Subject was diagnosed with cancer and receives oral oncology medication. 5. Subject is intended to receive Afinitor OR Sutent OR Lenvima during the 2 months study period. 6. Subject takes medication therapy at home. 7. Subject is fluent in one of the following languages: Hebrew, English, Russian, Arabic. Exclusion Criteria: 1. Subject has physical or mental disabilities which prevents their enrolment in this study, such as poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent or use the ReX-C dispensing unit effectively. 2. Subject failed to extract 2 Tic-Tacs with the Rex-C device during training. 3. Subject is participating in another clinical study that does not permit participation in two studies simultaneously. 4. Subject is at end stage or terminal illness with anticipated life expectancy of less than 3 months.
References
Publications (0)
Data not yet available