Improving Lenvatinib Treatment for Thyroid Cancer Using a Mobile App
A Controlled Trial for Improving the Response to Lenvatinib in Patients With Drug-resistant Thyroid Cancer by Chronobiology
EARLY_PHASE1 · Hadassah Medical Organization · NCT06321120
This study tests if using a mobile app to adjust the timing and dosage of lenvatinib can help thyroid cancer patients feel better while reducing side effects.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hadassah Medical Organization (other) |
| Drugs / interventions | Lenvatinib |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT06321120 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of integrating chronobiology into lenvatinib treatment regimens for thyroid cancer patients through a mobile application. Participants will follow a physician-approved schedule that adjusts lenvatinib dosages and administration timing based on variability principles. The study seeks to minimize adverse effects associated with lenvatinib while enhancing treatment adherence and overall effectiveness. By utilizing an AI-driven approach, the trial explores personalized treatment adjustments to optimize patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who are currently being treated with lenvatinib and experiencing dose-limiting adverse effects.
Not a fit: Patients with a history of drug abuse, those who are pregnant or planning pregnancy, or those currently involved in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment efficacy and reduced side effects for thyroid cancer patients receiving lenvatinib.
How similar studies have performed: Previous studies have shown promise in using AI-driven approaches to optimize treatment regimens in other medical contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-80 years 2. Lenvatinib treated cancer patients, who suffer from loss of response of dose-limiting adverse effects. Exclusion Criteria: 1. Current or history of drug abuse 2. Pregnancy/lactation/planned pregnancy 3. The subject is currently enrolled in or has not yet completed at least 60 days since ending another investigational device or drug trial. 4. Unable to comply with study requirements.
Where this trial is running
Jerusalem
- Hadassah Medical Organization — Jerusalem, Israel (RECRUITING)
Study contacts
- Study coordinator: Aharon Popovtzer, MD
- Email: ARON@HADASSAH.ORG.IL
- Phone: 972509010225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lenvatinib Treatment, cancer, lenvatinib, constrained disorder principle, digital pill