Using Chronobiology to Improve Lenvatinib Efficacy
NCT06321120 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2024-03-20
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.
Conditions
- Lenvatinib Treatment
Interventions
- DRUG
-
variability-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.
Sponsors & Collaborators
-
Hadassah Medical Organization
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-01
- Primary Completion
- 2024-04-30
- Completion
- 2024-06-30
Countries
- Israel
Study Locations
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