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

Sponsor
First People's Hospital of Hangzhou (Other)
Overall Status
Unknown status
CT.gov ID
NCT04242927
Collaborator
Zhejiang University (Other)
36
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nicotinic acid +Routine care
  • Drug: Routine care
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
Actual Study Start Date :
Mar 9, 2020
Anticipated Primary Completion Date :
Mar 9, 2021
Anticipated Study Completion Date :
Mar 9, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First People's Hospital of Hangzhou Hangzhou Zhejiang China 310006

    Sponsors and Collaborators

    • First People's Hospital of Hangzhou
    • Zhejiang University

    Investigators

    • Principal Investigator: Shenglin Ma, MD, First People's Hospital of Hangzhou

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First People's Hospital of Hangzhou
    ClinicalTrials.gov Identifier:
    NCT04242927
    Other Study ID Numbers:
    • NAVI
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Apr 1, 2020
    Last Verified:
    Mar 1, 2020
    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
    Additional relevant MeSH terms:
    Nicotinic Acids
    Niacin
    Niacinamide

    Study Results

    No Results Posted as of Apr 1, 2020