NCT07911891CompletedPhase 2
Oral Mecobalamin for TKI-Associated Hand-Foot Syndrome in Advanced Thyroid Cancer
Oral Mecobalamin for the Treatment of Tyrosine Kinase Inhibitor-Associated Hand-Foot Syndrome in Patients With Advanced Thyroid Cancer: A Single-Center, Open-Label, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
This study evaluates the efficacy and safety of oral mecobalamin for the treatment of tyrosine kinase inhibitor (TKI)-associated hand-foot syndrome (HFS) in patients with advanced thyroid cancer. 100 patients will be randomly assigned to receive either routine skin care with topical urea ointment alone (control group) or routine skin care plus oral mecobalamin (0.5 mg three times daily) for 8 weeks. The primary outcome is the proportion of patients with HFS grade improvement at week 8.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 25 Oct 2026
- Start date
- 12 Apr 2025
- Primary completion date
- 28 Dec 2025
- Lead sponsor
- Li Zhihui
- Diseases
- Thyroid cancer
- NCT number
- NCT07911891
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 12 Apr 2025 to the primary completion date, 28 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant vitamin B12 deficiency or requiring long-term vitamin B12 supplementation
- Received other drugs for HFS treatment within 4 weeks before enrollment
Other illness
- Pre-existing primary peripheral neuropathy, diabetic foot, severe skin disease, or hand/foot trauma
- Allergy to mecobalamin or urea ointment components
- Severe cardiac, hepatic, or renal dysfunction
Other
- Pregnant or lactating women
- Inability to cooperate with follow-up
Who the study is looking for
- Pathologically confirmed advanced thyroid cancer (including papillary, follicular, medullary, and other types)
- Currently receiving TKI therapy (sorafenib, lenvatinib, cabozantinib, etc.)
- Developed TKI-related hand-foot syndrome, CTCAE v5.0 grade 1-3
- Age 18-75 years, either gender
- Estimated survival time ≥3 months
- Voluntarily signed informed consent form
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.