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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinic acid + Routine care | Experimental | Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care. |
|
| Routine care | Active Comparator | Routinely apply urea ointment and provide best supportive care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinic acid +Routine care | Drug | Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hand-Foot Reaction Quality of Life (HF-QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueqin Chen, MD | Contact | +8613735430109 | chenlucy1437@aliyun.com | |
| Shenglin Ma, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Shenglin Ma, MD | First People's Hospital of Hangzhou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First People's Hospital of Hangzhou | Recruiting | Hangzhou | Zhejiang | 310006 | China |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Routine care | Drug | Routinely apply urea ointment and provide best supportive care. |
|
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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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |