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

Overview

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.

Full Title of Study: “Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 9, 2021

Interventions

  • 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.
  • Drug: Routine care
    • Routinely apply urea ointment and provide best supportive care.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Routine care
    • Routinely apply urea ointment and provide best supportive care.

Clinical Trial Outcome Measures

Primary Measures

  • Response rate of VEGFR inhibitor-associated hand-foot skin reaction
    • Time Frame: 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
    • Time Frame: 2 year
    • Proportion of patients who achieve NCI CTCAE v5.0 – PPE grade 0.

Secondary Measures

  • Dose adjustment/withdrawal ratio
    • Time Frame: 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)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First People’s Hospital of Hangzhou
  • Collaborator
    • Zhejiang University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shenglin Ma, MD, Principal Investigator, First People’s Hospital of Hangzhou
  • Overall Contact(s)
    • Xueqin Chen, MD, +8613735430109, chenlucy1437@aliyun.com

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