Topical Meilian Fuxin liquid to prevent radiation dermatitis in head and neck cancer

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 interventional phase 2/3 trial compares topical Periplaneta americana–derived Meilian Fuxin Solution with an identical placebo applied twice daily to the irradiated skin from the start through the end of radiotherapy. Participants are assigned to receive either the active solution or placebo and skin reactions are measured at baseline and at regular intervals using RTOG criteria. Safety is monitored by recording local and systemic adverse events throughout treatment and follow-up. The trial is conducted at Sichuan University West China Hospital and targets patients receiving radical or adjuvant radiotherapy for head and neck cancers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
2. Diagnosis and Treatment: Patients with head and neck cancer (including nasopharyngeal carcinoma) who have been confirmed by histopathology and require radical radiotherapy or postoperative adjuvant radiotherapy.
3. Performance Status: Patients with an ECOG Performance Status score of 0 to 2.
4. Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
2. Baseline Skin Condition: Baseline skin condition in the treatment area that may interfere with efficacy assessment (e.g., presence of open wounds, infection, rash, psoriasis, etc.).
3. Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
4. Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
5. Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
6. Investigator Discretion: Subjects judged by the investigator to be unsuitable for participation in this clinical study.

Where it's running

• Sichuan University West China Hospital, Chengdu, Sichuan
  Chengdu, Sichuan, China Recruiting
• Sichuan University West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Principal investigator: Xingchen Peng — West China Hospital
• Study coordinator: Xingchen Peng
• Email: pxx2014@163.com
• Phone: +86 18980606753

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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.