A Phase 2 interventional study of Mecobalamin and Urea Ointment in Thyroid Cancer and Hand-foot Syndrome, sponsored by Li Zhihui. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Li Zhihui · Phase 2, Interventional, and Treatment
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.
Background: Hand-foot syndrome is a common skin toxicity associated with TKI therapy in advanced thyroid cancer, which often leads to dose reduction or treatment discontinuation. There is currently no standard effective treatment for TKI-related HFS. Mecobalamin, as an active form of vitamin B12, has been widely used for peripheral neuropathy and may have a therapeutic effect on HFS by improving nerve repair and reducing inflammation.
Methods: This is a single-center, open-label, randomized controlled trial conducted at West China Hospital, Sichuan University. Eligible patients are those with advanced thyroid cancer receiving TKI therapy who develop HFS (Common Terminology Criteria for Adverse Events (CTCAE) grade 1-3). Patients will be randomized 1:1 to either the control group (routine skin care with topical urea ointment 3 times daily) or the mecobalamin group (routine skin care plus oral mecobalamin 0.5 mg 3 times daily) for 8 weeks. The primary endpoint is the proportion of patients with HFS grade improvement ≥1 from baseline to week 8. Secondary endpoints include changes in VAS (visual analog scale) pain score, KPS (Karnofsky Performance Status) performance status, TKI dose adjustment rate, and adverse events.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's enrollment of 100 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →This is the only study on the registry with Li Zhihui as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive routine skin care with topical urea ointment 3 times daily for 8 weeks.
Other: Urea Ointment
Patients receive routine skin care plus oral mecobalamin 0.5 mg 3 times daily for 8 weeks.
Drug: Mecobalamin · Other: Urea Ointment
Oral mecobalamin 0.5 mg, 3 times daily, for 8 weeks.
Also known as: Methylcobalamin
Topical urea ointment applied to hands and feet 3 times daily, for 8 weeks.
Proportion of patients with HFS grade improvement ≥1 at week 8
HFS grade is assessed by CTCAE v5.0 criteria. Improvement ≥1 grade means the HFS severity decreases by at least one level from baseline to week 8.
Time frame: Week 8
Change in VAS pain score from baseline to week 8
VAS pain score ranges from 0 (no pain) to 10 (worst pain). Change score = baseline score - week 8 score.
Time frame: Week 8
Change in KPS performance status from baseline to week 8
KPS score ranges from 0 (death) to 100 (normal activity). Change score = week 8 score - baseline score.
Time frame: Week 8
Proportion of patients requiring TKI dose adjustment due to HFS
Patients who require TKI dose reduction, interruption, or discontinuation due to HFS during the 8-week study period.
Time frame: 8 weeks
Incidence of adverse events related to study medication
All adverse events assessed by CTCAE v5.0 criteria, classified as related or unrelated to study medication.
Time frame: 8 weeks
Plan to share: No
Ran from Apr 2025 to primary completion in Dec 2025, 8 months.
Of 77 non-industry phase 2 interventional studies under Thyroid Neoplasms, half reached primary completion within 84 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 124. This study's 8 months is below that.
Counting every sponsor, half of 92 studies reached it within 73 months; a quarter within 39 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mecobalamin