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

Phase 2

• Conditions: Hand-Foot Skin Reaction (HFSR)
• Interventions: Drug: Routine care; Drug: Nicotinic acid +Routine care

• Registration Number: NCT04242927
• Lead Sponsor: First People's Hospital of Hangzhou

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2020-03
• Study Start: 2020-03-09
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-01
• Primary Completion: 2021-03-09
• Study Completion: 2022-03-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine care	Routine care	Routinely apply urea ointment and provide best supportive care.
Nicotinic acid + Routine care	Nicotinic acid +Routine care	Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.

Primary Outcome Measures

Name	Time	Method
Response rate of VEGFR inhibitor-associated hand-foot skin reaction	2 year	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).
Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction	2 year	Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.

Secondary Outcome Measures

Name	Time	Method
Dose adjustment/withdrawal ratio	2 year	Proportion of patients who need dose adjustment or withdrawal of VEGFR inhibitors, such as sorafenib, regorafenib, anlotinib, and apatinib.
Hand-Foot Reaction Quality of Life (HF-QoL)	2 year	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.

Trial Locations

Locations (1)

First People's Hospital of Hangzhou; 🇨🇳 Hangzhou, Zhejiang, China