A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Hand-Foot Skin Reaction (HFSR)

Treatments: Drug: Routine care; Drug: Nicotinic acid +Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT04242927

NAVI

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

Nicotinic acid + Routine care

Experimental group

Description:

Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.

Treatment:

Drug: Nicotinic acid +Routine care

Routine care

Active Comparator group

Description:

Routinely apply urea ointment and provide best supportive care.

Treatment:

Drug: Routine care