OncologyNCT04091711
Evaluation of ReX-C® System for Medication Adherence in Oncology Patients Taking Oral Oncolytics
A study testing ReX-C system in people with Oncology and Adherence, Medication, run by Dosentrx Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Adherence, Medication, Side Effect
- What is being tested?
- ReX-C system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Apr 2020to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and during training successfully achieves 2 administrations of "demo" pills (Tic-Tac mints) by the ReX-C.
- Subject is able to read and understand the Informed Consent Form.
- Subject was diagnosed with cancer and receives oral oncology medication.
- Subject is intended to receive Afinitor OR Sutent OR Lenvima during the 2 months study period.
- Subject takes medication therapy at home.
- Subject is fluent in one of the following languages: Hebrew, English, Russian, Arabic.
Who cannot join
- 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.
- Subject failed to extract 2 Tic-Tacs with the Rex-C device during training.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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®.
- Conditions
- Oncology, Adherence, Medication, Side Effect
- Being tested
- ReX-C system
- Medical subject headings
- Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReX-C systemDevice
Oral oncolytic medications are dispensed to patients via ReX-C system
| Study group | Role | What they receive |
|---|---|---|
| ReX-C intervention | Experimental | 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. Receives: Device: ReX-C system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of safety events during administration of oral oncolytic medications by ReX-C
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.
Measured: 8 weeks
Rate of subjects feel comfortable to use ReX-C for pill intake and side effects report
At least 70% of subjects: -
- Complete the duration of the study with Rex-C.
- Define the system as comfortable to use and are willing to continue using it for their oncolytic medication treatment.
Measured: 8 weeks
Rate of adherence (number of pill intakes) during treatment with ReX-C
- Up to 90% of pills are taken as prescribed
- At least 80% of subjects follow treatment instructions, and response to ReX-C reminders and alerts.
Measured: 8 weeks
Rate of monitoring subjects' home-based treatment by the clinical staff and satisfaction of the clinical team
At least 80% of clinical team:
- are satisfied with the use of the system and report that it is beneficial in monitoring patients' adherence and response to treatment.
- report that the system facilitates better communication with the patient and provides more appropriate real-time response compared to routine care.
- are interested in integrating the system into the oncology department for routine administration of home-based medication for oncology patients.
Measured: 8 weeks
Secondary outcomes (1)
Number of actual pill intakes by ReX-C system, compared with the number of prescribed pills
Test if the number of pills prescribed and given to the subjects is higher than that actually taken during the study.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start21 Apr 2020
- Primary completionDec 2022 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: Awaiting next model of the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dosentrx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravit Geva, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091711
- Sponsor's protocol ID
- RXC-034-2019-CLE
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04091711
- Acronym / sponsor ID
- RXC-034-2019-CLE
- Conditions
- Oncology, Adherence, Medication, Side Effect
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting next model of the device
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dosentrx Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ReX-C intervention | Experimental | Device: ReX-C systemSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and during training successfully achieves 2 administrations of "demo" pills (Tic-Tac mints) by the ReX-C.
- Subject is able to read and understand the Informed Consent Form.
- Subject was diagnosed with cancer and receives oral oncology medication.
- Subject is intended to receive Afinitor OR Sutent OR Lenvima during the 2 months study period.
Key exclusion criteria (4 listed)
- 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.
- Subject failed to extract 2 Tic-Tacs with the Rex-C device during training.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReX-C systemOral oncolytic medications are dispensed to patients via ReX-C system | Device | ReX-C intervention |
Primary outcome
Number of safety events during administration of oral oncolytic medications by ReX-C
Time frame: 8 weeks
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.
Rate of subjects feel comfortable to use ReX-C for pill intake and side effects report
Time frame: 8 weeks
At least 70% of subjects: - * Complete the duration of the study with Rex-C. * Define the system as comfortable to use and are willing to continue using it for their oncolytic medication treatment.
Rate of adherence (number of pill intakes) during treatment with ReX-C
Time frame: 8 weeks
* Up to 90% of pills are taken as prescribed * At least 80% of subjects follow treatment instructions, and response to ReX-C reminders and alerts.
Rate of monitoring subjects' home-based treatment by the clinical staff and satisfaction of the clinical team
Time frame: 8 weeks
At least 80% of clinical team: * are satisfied with the use of the system and report that it is beneficial in monitoring patients' adherence and response to treatment. * report that the system facilitates better communication with the patient and provides more appropriate real-time response compared to routine care. * are interested in integrating the system into the oncology department for routine administration of home-based medication for oncology patients.
1 secondary outcome
Number of actual pill intakes by ReX-C system, compared with the number of prescribed pills
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravit Geva, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReX-C system in people with Oncology and Adherence, Medication, run by Dosentrx Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of safety events during administration of oral oncolytic medications by ReX-C (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.