Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
Sponsor study identifier
interventional
36
1 country
1
Study Start
March 9, 2020
Actual (reported)Primary Completion
March 9, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 9, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 9, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2020
Actual (reported)January 27, 2020
Actual (reported)March 9, 2020
Actual (reported)March 9, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 9, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Dose adjustment/withdrawal ratio
2 year
Hand-Foot Reaction Quality of Life (HF-QoL)
2 year
Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
Routinely apply urea ointment and provide best supportive care.
Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006, China
Shenglin Ma, MD
First People's Hospital of Hangzhou
Shenglin Ma, MD
CONTACT
First Submitted
January 23, 2020
First Posted
January 27, 2020
Study Start
March 9, 2020
Actual (reported)Primary Completion
March 9, 2021
Estimated (date passed)Sorafenib-induced Hand- Foot Skin Reaction Treatment
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 9, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 1, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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