RecruitingEarly Phase 1NCT06321120

Using Chronobiology to Improve Lenvatinib Efficacy

A Controlled Trial for Improving the Response to Lenvatinib in Patients With Drug-resistant Thyroid Cancer by Chronobiology

Sponsor

Hadassah Medical Organization

Enrollment

10 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Lenvatinib Treatment

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study uses the science of body clocks (chronobiology) to explore whether timing lenvatinib doses at specific times of day — aligned with the body's natural rhythms — can make the drug work better or cause fewer side effects in cancer patients. **You may be eligible if...** - You are between 18 and 80 years old - You are currently being treated with lenvatinib for cancer - You are experiencing either a loss of response to lenvatinib OR side effects that are limiting your dose **You may NOT be eligible if...** - You have a current or past history of drug abuse - You are pregnant, breastfeeding, or planning to become pregnant - You have been in another clinical trial within the past 60 days and have not yet completed it - You are unable to follow the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGvariability-based lenvatinib regimen

Dosages and administration times were tailored within individual predefined ranges to accommodate personalized therapeutic regimens. As per protocol, the daily dose was limited to match or remain below the patients' pre-enrollment dosage level. In the initial 4 weeks of the follow-up, participants followed a fixed standard regimen with the app serving as a reminder, allowing for an adaptation period. Subsequently, the algorithm-driven treatment plan was implemented for an additional 10 weeks.

Locations(1)

Hadassah Medical Organization

Jerusalem, Israel

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NCT06321120