Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321120
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-11
Brief Title:
Using Chronobiology to Improve Lenvatinib Efficacy
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
A Controlled Trial for Improving the Response to Lenvatinib in Patients With Drug-resistant Thyroid Cancer by Chronobiology
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this proof-of-concept clinical trial is to assess the efficacy and safety of chronobiology implementation into lenvatinib treatment regimens of thyroid cancer patients via a mobile application
Participants will use a mobile application to follow variability-based physician approved drug administration schedules
Participants will use a mobile application to follow variability-based physician approved drug administration schedules
Detailed Description:
Systemic treatments for thyroid cancer have emerged in the past decade accompanied by a deeper understanding of its underlying molecular mechanisms Among these lenvatinib a multi-targeted tyrosine kinase inhibitor was approved as a monotherapy for treating locally advanced or metastatic radioactive iodine refractory differentiated thyroid cancer Despite its efficacy lenvatinib is associated with a spectrum of adverse events AEs including hypertension fatigue proteinuria and gastrointestinal disturbances which often necessitate dose reduction interruption or permanent discontinuation To overcome these challenges the investigators address to the Constrained Disorder Principle CDP an innovative approach that emphasizes the exploration of constrained variability in treatment regimens to optimize drug effectiveness and minimize AEs In other disease contexts such as congestive heart failure multiple sclerosis and chronic pain the integration of CDP-based second-generation artificial intelligence AI systems into treatment regimens has shown promising results in enhancing therapeutic outcomes by dynamically adjusting treatment parameters The investigators hypothesize that a personalized dynamic adjustment of lenvatinib dosages and administration timing guided by an AI-driven approach via a mobile application may reduce AEs improve adherence and enhance overall treatment efficacy In this proof-of-concept study the investigators aim to evaluate the feasibility and efficacy of utilizing a CDP-based second-generation AI system to optimize the therapeutic regimen of lenvatinib in patients with cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None