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

Hand-Foot Skin Reaction (HFSR) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04242927
• Other study ID #: NAVI
• Status: Recruiting
• Phase: Phase 2
• Start date: March 9, 2020
• Est. completion date: March 9, 2022

Study information

• Verified date: March 2020
• Source: First People's Hospital of Hangzhou
• Contact: Xueqin Chen, MD
• Phone: +8613735430109
• Email: chenlucy1437[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand-Foot Skin Reaction (HFSR)

Intervention

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

Locations

Country	Name	City	State
China	First People's Hospital of Hangzhou	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou	Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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