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The incidence of radiation-induced skin injury is high, and effective preventive measures are currently lacking. This study evaluates the role of the skin protective agent Pinoxin in preventing skin injury. Patients are randomly assigned into two prospective groups: treatment group and control group. In treatment group, patients will receive Pinoxin treatment. In control group,patients will receive placebo treatment. The rate of grade 2 or greater skin injury will be analyzed.
This study is a prospective, randomized controlled, multicenter phase II study, with a design of superior efficacy,to compare the efficacy of Pinoxin and placebo in protecting radiation induced skin injury. We will consecutively enrolled patients who were diagnosed with cancer,and will receive radiotherapy at the dose of 50Gy or higher and radiation field is near skin. A total of 202 patients will be Randomized 1:1 to the treatment group and control group. In treatment group, patients will be sprayed Pinoxin,four times daily (morning, noon, evening, bedtime) from radiotherapy start until 2 weeks post-radiotherapy (continuous, including weekends) .In control group, patiants will received vitamin B12 as placebo. The dosing frequency is the same as that in the treatment group. Unblinding will be triggered if Grade 3 or higher reactions occur. If participants in the placebo control group develop Grade 3 or higher skin injury, they are permitted to use Pinoxin or opt for other appropriate symptomatic treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Receiving prophylactic skin administration of Pinoxin. |
|
| control | Placebo Comparator | Receiving prophylactic skin administration of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pinoxin | Drug | Treatment group will receive prophylactic skin administration of Pinoxin,which is kind of Skin Protective Agent. |
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| Measure | Description | Time Frame |
|---|---|---|
| adverse effect | Incidence of acute skin injury of Grade 2 or higher | from the start of radiotherapy to 3 months |
| ≥ grade 2 acute skin injury | Incidence of acute skin injury of Grade 2 or higher | from the start of radiotherapy to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Zhang, MD | Contact | +86-021-64175590 | zhen_zhang@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Placebo | Drug | Treatment group will receive prophylactic skin administration of placebo |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
|