Pinoxin to prevent radiation skin injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-arm phase II trial enrolling 202 adult cancer patients who will receive radiotherapy of 50 Gy or higher with fields close to the skin. Participants are randomized 1:1 to receive either topical Pinoxin spray or a vitamin B12 placebo, applied four times daily from the start of radiotherapy until two weeks after completion. The primary outcome is the rate of grade 2 or greater radiation-induced skin injury; unblinding is allowed for grade 3 or higher reactions and placebo patients with severe injury may receive Pinoxin or other treatments. The design aims to show superior efficacy of Pinoxin compared with placebo in preventing clinically meaningful skin toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years, regardless of gender.
2. Pathologically diagnosed with a malignant tumor.
3. Scheduled to receive long-course radiotherapy with a total dose of ≥50 Gy, in accordance with standard treatment guidelines.
4. No prior history of radiotherapy.
5. Has provided signed and dated informed consent, indicating that the patient has been informed of all relevant aspects of the study.
6. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. History of dermatologic conditions (e.g., vitiligo, psoriasis, etc.) or collagen vascular diseases.
2. Planned hypofractionated radiotherapy regimen.
3. Recent use (e.g., within 3 months) of similar topical protective agents.
4. Known hypersensitivity to any related components or materials.
5. Immunodeficiency disorders.
6. Women who are pregnant or lactating.
7. Any other condition that, in the investigator's judgment, may compromise patient safety or protocol compliance. This includes severe concomitant illnesses (including psychiatric disorders) requiring active treatment, significant laboratory abnormalities, or significant social/familial factors.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting
• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Zhen Zhang, MD
• Email: zhen_zhang@fudan.edu.cn
• Phone: +86-021-64175590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.