Clinical trial NCT04091711: Evaluation of ReX-C® System for Medication Adherence in Oncology Patients Taking Oral Oncolytics
Official title: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Oncology
Adherence, Medication
Side Effect
Lead sponsor: Dosentrx Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open study for subjects receiving home-based oral oncolytic treatment. Subjects receive these medication by ReX-C device. Medication adherence, treatment instructions and side effects are recorded and monitored online in real time during the Study, by the ReX-C system.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: ReX is a hand-held, mobile device intended to provide solid oral medication on patient demand according to a pre-programmed treatment protocol. ReX addresses poor patient adherence, tracks patient's response to treatment and enhances patient engagement to therapy. The system comprises a reusable drug dispensing unit (Dispenser), a disposable Cassette containing the prescribed medication, a cellphone app, and the ReX cloud. The Dispenser manages pill administration. It includes a touch screen which guides the user and presents patient-specific clinical surveys and therapy information. The Dispenser contains a chargeable battery and indicators demonstrating device and battery status; a pill window enabling pills to be viewed; operational sensors; and communication to an app on cellphones. The patient receives the Cassette from the pharmacy, pre-filled with his/her specific medication. The Cassette is inserted into the Dispenser where it is locked in place. All therapy and patient survey data are transferred to a patient-specific domain on DosentRx' proprietary web-based cloud, named Dose-E®.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of safety events during administration of oral oncolytic medications by ReX-C
timeFrame: 8 weeks
measure: Rate of subjects feel comfortable to use ReX-C for pill intake and side effects report
timeFrame: 8 weeks
measure: Rate of adherence (number of pill intakes) during treatment with ReX-C
timeFrame: 8 weeks
measure: Rate of monitoring subjects' home-based treatment by the clinical staff and satisfaction of the clinical team
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of actual pill intakes by ReX-C system, compared with the number of prescribed pills
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Oncology Unit, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Ravit Geva, MD
role: PRINCIPAL_INVESTIGATOR
References: