Using Chronobiology to Improve Lenvatinib Efficacy
A Controlled Trial for Improving the Response to Lenvatinib in Patients With Drug-resistant Thyroid Cancer by Chronobiology
Hadassah Medical Organization
10 participants
Mar 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Age 18-80 years
- Lenvatinib treated cancer patients, who suffer from loss of response of dose-limiting adverse effects.
Exclusion Criteria4
- Current or history of drug abuse
- Pregnancy/lactation/planned pregnancy
- The subject is currently enrolled in or has not yet completed at least 60 days since ending another investigational device or drug trial.
- Unable to comply with study requirements.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT06321120