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Mec-HFS-TCNCT07911891

Oral Mecobalamin for TKI-Associated Hand-Foot Syndrome in Advanced Thyroid Cancer

StatusCompleted
PhasePhase 2
SponsorLi Zhihui
Primary completion
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Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Proportion of patients with HFS grade improvement ≥1 at week 8
Timeframe: Week 8

Secondary (4)

Change in VAS pain score from baseline to week 8
Change in KPS performance status from baseline to week 8
Proportion of patients requiring TKI dose adjustment due to HFS
Incidence of adverse events related to study medication

Arms and interventions

Control GroupPlacebo comparator

Patients receive routine skin care with topical urea ointment 3 times daily for 8 weeks.

Mecobalamin GroupExperimental

Patients receive routine skin care plus oral mecobalamin 0.5 mg 3 times daily for 8 weeks.

Drugs: Mecobalamin

Other: Urea Ointment

Sites

1 site in 1 country

  • West China Hospital, Sichuan UniversityChengdu, Sichuan, China