Chemotherapy-induced NeurotoxicityTRUST_MENCT07159854
Telerehabilitation in Central and Peripheral Neurological Sequelae From Chemotherapy
A study testing RICORDO-DTx system, HOMING system and Home-based training program in people with Chemotherapy-induced Neurotoxicity, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neurotoxicity
- What is being tested?
- RICORDO-DTx system, HOMING system and Home-based training program
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult subjects (>18 years old) with central and/or peripheral neurotoxic sequelae following a history of cancer treated with chemotherapeutic agents (Cisplatin and Taxanes), in accordance with the criteria of the International Cognitive Cancer Task Force (Wefel et al., 2011. 10.1016/S1470-2045(10)70294-1)
- agreement to participate with the signature of the informed consent form;
Who cannot join
- Ongoing chemotherapy treatment;
- Pre-existing neurological or psychiatric comorbidities (e.g., epilepsy, post-stroke disability, neurodegenerative diseases, genetically based polyneuropathy);
- Severe visual or hearing impairments that could interfere with the use of technology;
- Severe cognitive impairment (Mini-Mental State Examination score <18);
- Severe postural disability associated with a high risk of falling at home, as documented in the clinical evaluation;
- Contraindications to undergoing MRI examination;
- Ongoing rehabilitation treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Federica Rossetto contact
Italy1 site
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Milan, 20148
Francesca Baglio, +390240308952, fbaglio@dongnocchi.it
Francesca Baglio
About this study
Official title: TeleRehabilitation: an Innovative User-centered STrategic Approach for the treatMent of Central and Peripheral Neurological sEquelae From Chemotherapy - TRUST_ME
The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Participants will be randomized (with an allocation ratio of 1:1) into the experimental group (TRUST_ME - 15 sessions of motor and cognitive activities delivered at home through a TR approach using the Maia platform) and Treatment as Usual (15 sessions of multimedia content of educational/rehabilitation activities delivered via telemedicine platfom). It expected that the TR system to be considered acceptable in terms of efficiency (usability and acceptability of the technologies) and clinically effective, with positive impacts on both quality of life and central and peripheral functioning in these patients.
- Conditions
- Chemotherapy-induced Neurotoxicity
- Being tested
- RICORDO-DTx system, HOMING system, Home-based training program
- Keywords
- Chemotherapy-induced neurotoxicity, rehabilitation, telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICORDO-DTx systemDevice
Participants with will undergo a cognitive enhancement program using the Astir RICORDO-DTx system (http://www.ricordo-dtx.com), which allows for the personalization of rehabilitative content based on the needs of the target population and can be delivered remotely.
HOMING systemDevice
Participants will also undergo motor rehabilitation sessions focused on improving balance, gait, and muscular endurance using the HOMING system (https://www.tecnobody.com/homing).
Home-based training programDevice
Subjects will view videos on Tablet. The treatment will be provided via a digital medicine platform on a mobile device (tablet).
| Study group | Role | What they receive |
|---|---|---|
| TRUST_ME | Experimental | A cycle of motor and cognitive activities delivered at home through a telerehabilitation approach using the Maia platform by ABmedica (https://abmedica.it/prodotti-ab-medica/maia). The treatment will last 5 weeks with a frequency of three sessions a week (1 synchronous and 2 asynchronous). Receives: Device: RICORDO-DTx system; Device: HOMING system |
| Treatment as Usual | Placebo comparator | Home-based training instructions "as usual", consisting of multimedia content (i.e., videos of the educational/rehabilitation activities) delivered asynchronously via telemedicine platfom. The treatment will last 5 weeks with a frequency of three sessions a week. Receives: Device: Home-based training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)
PAM13 is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
Measured: Time Frame: Baseline, post-treatment (up to 5 weeks)
Secondary outcomes (9)
Change in Functional Assessment of Cancer Therapy-Cognitive Function - FACT-Cog (Fardell et al., 2022. 10.1002/pon.5928);
FACT-Cog is a 37 item self-report tool on 5-point Likert scale to assess perceived cognitive function in adult cancer patients with chemotherapy-induced cognitive problems
Measured: Baseline, post-treatment (up to 5 weeks)
Change in EORTC CIPN-20 questionnaire (Postam et al., 2005).
EORTC CIPN-20 is a 20-item self-report questionnaire to assess patients' experience of symptoms and functional limitations related to chemotherapy-induced peripheral neuropathy;
Measured: Baseline, post-treatment (up to 5 weeks)
Change in Patient Health Engagement Scale (PHE) (Graffigna et al., 2017)
Patient Health Engagement Scale (PHE-s) is a validated tool designed to measure a person's level of engagement in managing their own health, based on the Patient Health Engagement (PHE) Model.
Measured: Baseline, post-treatment (up to 5 weeks)
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Santangelo et al., 2015)
MoCA is a screening test for global cognitive functioning. It includes tasks involving several domains: visuospatial/executive function tests, naming, selective and sustained attention, language, abstraction, memory and orientation. High scores are indicative of better general cognitive performance.
Measured: Baseline, post-treatment (up to 5 weeks)
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)
TMT is a neuropsychological test that involves visual scanning (TMT-A) and dual-task (TMT-B). The TMT is scored by how long it takes to complete each part of the test. High execution times indicate poor performance.
Measured: Baseline, post-treatment (up to 5 weeks)
Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)
FCSRT is a visual memory test that maximises encoding specificity. It assesses learning (immediate recall) and visual long-term (delayed recall) memory of visual stimuli. The administration is divided into three phases: 1) Encoding phase: naming of stimuli (three boards with four coloured stimuli each) and verification of encoding with cue; 2) Immediate recall phase: free immediate recall + recall with a cue for not recalled stimuli (this sequence is repeated three times with interference task between trials); 3) deferred recall phase (after 30 minutes of non-verbal tasks): free deferred recall + recall with a cue for not recalled stimuli. Six scores can be obtained: Immediate Free Recall (spontaneous recall in the three trials; range 0-36); Immediate Total Recall (total recall in the three trials - range 0-36); Delayed-Free Recall (range 0-12); Delayed Total Recall (range 0-12); Index of Sensitivity of Cueing (ISC) and Number of intrusions. Higher scores indicate better performance.
Measured: Baseline, post-treatment (up to 5 weeks)
Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)
The Mini-BESTest aims to identify the disordered systems underlying the postural control responsible for poor functional balance. This tool is composed by 27 tasks (36 items in total) assessing bio-mechanical constraints, stability limits/verticality, anticipatory responses, postural responses, sensory orientation, and stability in gait. Each item is scored based on ordinal scale scoring from 0- 3 where 3 = best performances and 0 = worst performances. The total score is provided as a percentage. Higher scores are indicative of better performance.
Measured: Baseline, post-treatment (up to 5 weeks)
Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)
6' Minute Walking Test (6MWT) has been validated as a general indicator of overall physical performance and mobility for older people (Duncan et al 1993; Harad et al 1999). The total distance walked is measured.
Measured: Baseline, post-treatment (up to 5 weeks)
Change in strength level using a dynamometer
dynamometer
Measured: Baseline, post-treatment (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeurotoxicityStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Astir s.r.l.
- Responsible party
- Sponsor
- Investigators
- Francesca Baglio, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159854
- Sponsor's protocol ID
- TRUST_ME
- Acronym
- TRUST_ME
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeleRehabilitation: an Innovative User-centered STrategic Approach for the treatMent of Central and Peripheral Neurological sEquelae From Chemotherapy - TRUST_ME
- ClinicalTrials.gov ID
- NCT07159854
- Acronym / sponsor ID
- TRUST_ME / TRUST_ME
- Conditions
- Chemotherapy-induced Neurotoxicity
- Keywords
- Chemotherapy-induced neurotoxicity, rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Astir s.r.l.
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
The goal of this clinical trial is to validate the use of innovative tele-rehabilitation (TR) models in terms of efficiency and effectiveness in a pilot cohort of subjects with central and peripheral chemotherapy-induced neurotoxicity. Participants will be randomized (with an allocation ratio of 1:1) into the experimental group (TRUST_ME - 15 sessions of motor and cognitive activities delivered at home through a TR approach using the Maia platform) and Treatment as Usual (15 sessions of multimedia content of educational/rehabilitation activities delivered via telemedicine platfom). It expected that the TR system to be considered acceptable in terms of efficiency (usability and acceptability of the technologies) and clinically effective, with positive impacts on both quality of life and central and peripheral functioning in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRUST_ME | Experimental | Device: RICORDO-DTx system, Device: HOMING systemA cycle of motor and cognitive activities delivered at home through a telerehabilitation approach using the Maia platform by ABmedica (https://abmedica.it/prodotti-ab-medica/maia). The treatment will last 5 weeks with a frequency of three sessions a week (1 synchronous and 2 asynchronous). |
| Treatment as Usual | Placebo comparator | Device: Home-based training programHome-based training instructions "as usual", consisting of multimedia content (i.e., videos of the educational/rehabilitation activities) delivered asynchronously via telemedicine platfom. The treatment will last 5 weeks with a frequency of three sessions a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult subjects (>18 years old) with central and/or peripheral neurotoxic sequelae following a history of cancer treated with chemotherapeutic agents (Cisplatin and Taxanes), in accordance with the criteria of the International Cognitive Cancer Task Force (Wefel et al., 2011. 10.1016/S1470-2045(10)70294-1)
- agreement to participate with the signature of the informed consent form;
Key exclusion criteria (7 listed)
- Ongoing chemotherapy treatment;
- Pre-existing neurological or psychiatric comorbidities (e.g., epilepsy, post-stroke disability, neurodegenerative diseases, genetically based polyneuropathy);
- Severe visual or hearing impairments that could interfere with the use of technology;
- Severe cognitive impairment (Mini-Mental State Examination score <18);
- Severe postural disability associated with a high risk of falling at home, as documented in the clinical evaluation;
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 |
|---|---|---|
| RICORDO-DTx systemParticipants with will undergo a cognitive enhancement program using the Astir RICORDO-DTx system (http://www.ricordo-dtx.com), which allows for the personalization of rehabilitative content based on the needs of the target population and can be delivered remotely. | Device | TRUST_ME |
| HOMING systemParticipants will also undergo motor rehabilitation sessions focused on improving balance, gait, and muscular endurance using the HOMING system (https://www.tecnobody.com/homing). | Device | TRUST_ME |
| Home-based training programSubjects will view videos on Tablet. The treatment will be provided via a digital medicine platform on a mobile device (tablet). | Device | Treatment as Usual |
Primary outcome
Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)
Time frame: Time Frame: Baseline, post-treatment (up to 5 weeks)
PAM13 is a 13-item scale that assesses a person's underlying knowledge, skills and confidence integral to managing his or her health and healthcare. PAM13 total score ranging from 0 to 100. Higher values represent a better outcome. Specifically, individuals in the lowest activation level do not yet understand the importance of their role in managing their health and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self- management skills, and are resilient in times of stress or change.
9 secondary outcomes
Change in Functional Assessment of Cancer Therapy-Cognitive Function - FACT-Cog (Fardell et al., 2022. 10.1002/pon.5928);
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in EORTC CIPN-20 questionnaire (Postam et al., 2005).
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in Patient Health Engagement Scale (PHE) (Graffigna et al., 2017)
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment (MoCA; Santangelo et al., 2015)
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT part-A and part-B; Giovagnoli et al., 1996)
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in Static and dynamic balance measured by Mini-Best Test (Franchignoni et al., 2010)
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in Aerobic Capacity and Gait measured by 6' Minute Walking Test (6MWT)
Time frame: Baseline, post-treatment (up to 5 weeks)
Change in strength level using a dynamometer
Time frame: Baseline, post-treatment (up to 5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- internet page of InstitutionLink provided by the sponsor.
- internet page of Research UnitLink provided by the sponsor.
- 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.
Federica Rossetto contact
Francesca Baglio principal investigator
IRCCS Fondazione Don Carlo Gnocchi ONLUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RICORDO-DTx system, HOMING system and Home-based training program in people with Chemotherapy-induced Neurotoxicity, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Sep 2025. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Baglio (+390240308952, fbaglio@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004) (time frame: Time Frame: Baseline, post-treatment (up to 5 weeks)). 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 8 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.