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

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 Overview

• Status: Unknown
• Conditions: Hand-Foot Skin Reaction (HFSR)
• Intervention / Treatment: Drug: Nicotinic acid +Routine care; Drug: Routine care

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • First People's Hospital of Hangzhou
      • Contact: Xueqin Chen; Phone Number: +8613735430109; Email: chenlucy1437@aliyun.com
      • Sub-Investigator: Xueqin Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Nicotinic Acid 50 MG Oral Tablet
Active Comparator: Routine care; Routinely apply urea ointment and provide best supportive care.	Drug: Routine care; Routinely apply urea ointment and provide best supportive care.; Other Names: Urea ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response 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).	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.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose adjustment/withdrawal ratio	Proportion of patients who need dose adjustment or withdrawal of VEGFR inhibitors, such as sorafenib, regorafenib, anlotinib, and apatinib.	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.	2 year

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Collaborators: Zhejiang University
• Investigators: Principal Investigator: Shenglin Ma, MD, First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Anticipated): March 9, 2021
• Study Completion (Anticipated): March 9, 2022

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: NAVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No