Hand-Foot Skin Reaction (HFSR)
Conditions
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.
Interventions
DRUGNicotinic acid +Routine care
Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
DRUGRoutine care
Routinely apply urea ointment and provide best supportive care.
Sponsors
Zhejiang University
First People's Hospital of Hangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactXueqin Chen, MD
Backup ContactShenglin Ma, MD
Outcome results
None listed