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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242927
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Zhejiang University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hand-Foot Skin Reaction (HFSR) Drug: Nicotinic acid +Routine care Drug: Routine care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 9, 2020
Estimated Primary Completion Date : March 9, 2021
Estimated Study Completion Date : March 9, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Urea ointment




Primary Outcome Measures :
  1. 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).

  2. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242927


Contacts
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Contact: Xueqin Chen, MD +8613735430109 chenlucy1437@aliyun.com
Contact: Shenglin Ma, MD

Locations
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China, Zhejiang
First People's Hospital of Hangzhou Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Xueqin Chen    +8613735430109    chenlucy1437@aliyun.com   
Sub-Investigator: Xueqin Chen         
Principal Investigator: Shenglin Ma         
Sponsors and Collaborators
First People's Hospital of Hangzhou
Zhejiang University
Investigators
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Principal Investigator: Shenglin Ma, MD First People's Hospital of Hangzhou
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Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT04242927    
Other Study ID Numbers: NAVI
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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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:
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Nicotinic Acids
Niacin
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents