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

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    First People's Hospital of Hangzhou
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Updated on 19 February 2024
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Summary

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.

Details
Condition Hand-Foot Skin Reaction (HFSR)
Age 18years - 75years
Treatment Routine Care, Nicotinic acid +Routine care
Clinical Study IdentifierNCT04242927
SponsorFirst People's Hospital of Hangzhou
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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