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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
36
Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
Routinely apply urea ointment and provide best supportive care.
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
RECRUITINGResponse rate of VEGFR inhibitor-associated hand-foot skin reaction
Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0/1 (enrolled grade 2 patients) or grade 0-2 (enrolled grade 3 patients).
Time frame: 2 year
Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction
Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.
Time frame: 2 year
Dose adjustment/withdrawal ratio
Proportion of patients who need dose adjustment or withdrawal of VEGFR inhibitors, such as sorafenib, regorafenib, anlotinib, and apatinib.
Time frame: 2 year
Hand-Foot Reaction Quality of Life (HF-QoL)
Hand-Foot Reaction Quality of Life (HF-QoL) questionnaire, scoring results statistics. The HF-QoL symptom and daily activity total scores were transformed to a scale of 0 to 4, based on the sum of each unit-weighted item score divided by the maximum score. Higher scores on the HF-QoL indicate worse quality of life or greatersymptom burden.
Time frame: 2 year
Shenglin Ma, MD
CONTACT
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