REVIVE Prospective Registry Cohort Study
ConditionOropharyngeal Dysphagia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
The main purpose of this registry is to collect observational, long-term safety and effectiveness data in participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has completed the Month 24 visit in the REVIVE study.
Has received iltamiocel as part of the blinded portion of the REVIVE study.
Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
Disqualifiers
Has received placebo as part of the blinded portion of the REVIVE study.
Unable or unwilling to provide informed consent.
Not available for, or willing to comply with the follow-up evaluations as required by the protocol.
Trial population
Participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study will be considered for enrollment. Eligibility according to inclusion and exclusion criteria is based on the participant's status at time of enrollment (Informed Consent Form (ICF) completion). All eligible participants consenting to study participation are expected to complete follow-up visits on a yearly basis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.
Other interventionParticipants are followed observationally to collect long-term safety and effectiveness data after prior receipt of iltamiocel in the separate Revive clinical trial; no intervention is administered as part of this registry. Long-term safety outcomes and efficacy will be separated in analysis \& reporting
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: Tongue Dysphagia Oropharyngeal Cancer1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events
Iltamiocel-related adverse events (AEs) and iltamiocel-related serious adverse events (SAEs) assessed by the investigator. Long-term safety outcomes and efficacy outcomes will be separated in analysis and reporting.
Time frame
From baseline through 5 years of follow-up, assessed annually2
Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI)
Anterior tongue pressure measured using the Iowa Oral Performance Instrument (IOPI). Range 0-100 kPa, where a lower number indicates less strength.
Time frame
Baseline and annually up to 5 yearsSecondary outcomes
1
Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10)
Patient-reported dysphagia symptoms assessed using the Eating Assessment Tool (EAT-10) total score. Eating Assessment Tool (EAT-10), range 0-40, where higher scores indicate worse dysphagia symptoms. Survey consisting of 10 questions (see table below), each score on a scale of 0-4, with 0= no problem, 4= severe problem. 922 Belafsky et al. Eating Assessment Tool TABLE 3. EATING ASSESSMENT TOOL (EAT-10) Circle the appropriate response. To what extent are the following scenarios problematic for you? 1. My swallowing problem has caused me to lose weight. 2. My swallowing problem interferes with my ability to go out for meals. 3. Swallowing liquids takes extra effort. 4. Swallowing solids takes extra effort. 5. Swallowing pills takes extra effort. 6. Swallowing is painful. 7. The pleasure of eating is affected by my swallowing. 8. When I swallow food sticks in my throat. 9. I cough when I eat. 10. Swallowing is stressful
Time frame
Baseline and annually up to 5 years2
Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ)
Patient-reported smell and taste function assessed using the ChemoSensory Smell and Taste Questionnaire (CSQ). Consists of 8 items divided into two subscales: 4 items for smell and 4 items for taste and each with a range of 1 to 5, where 1 is never, 2 is Rarely, 3 is Sometimes, 4 is Frequently and 5 is Always. Each scale ranges from 4 to 20, where higher scores indicate better chemosensory function.
Time frame
Baseline and annually up to 5 years3
Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS)
Functional oral intake assessed using the Functional Oral Intake Scale (FOIS). It is a 7-level ordinal scale used to document the functional level of oral food and liquid intake in patients with dysphagia. It ranges from Level 1 (no oral intake/tube-dependent) to Level 7 (full oral intake without restrictions), where the higher the score the less oral intake restrictions.
Time frame
Baseline and annually up to 5 years4
Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI)
Dysphagia-related quality of life assessed using the MD Anderson Dysphagia Inventory (MDADI). It is a 20-item questionnaire that measures swallowing-related quality of life, scoring from 20 to 100. Higher scores indicate better functioning, with 20 representing the lowest and 100 the highest.
Time frame
Baseline and annually up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
Cook MyoSite
Collaborator
Source ClinicalTrials.gov
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