Clinical trial · Interventional
A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions
Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
NCT04242927CI-TRIAL-00044393unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hand-Foot Skin Reaction (HFSR) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nicotinic acid +Routine care | Drug | — | UNRESOLVED |
| Routine care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nicotinic acid + Routine care
- description
- Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
- interventionNames
- Drug: Nicotinic acid +Routine care
- type
- ACTIVE_COMPARATOR
- label
- Routine care
- description
- Routinely apply urea ointment and provide best supportive care.
- interventionNames
- Drug: Routine care
Primary outcomes (2)
- measure
- Response rate of VEGFR inhibitor-associated hand-foot skin reaction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting * HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE * Age from 18 to 75 years. * Life expectancy of at least 3 months at Day 1 Exclusion Criteria: * History of allergy to B vitamins * Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction * Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors. * History of psychiatric drugs substance abuse and fails to quit it or has amental disorder * Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception
References
Publications (0)
Data not yet available
No reference posted for this study.