RecruitingNot ApplicableNCT07081074

ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer


Sponsor

West China Hospital

Enrollment

40 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Radiation dermatitis is a common complication in head and neck squamous cell carcinoma patients receiving radiotherapy. This study proposes an ROS-scavenging amino acid-based nanolipid to prevent oxidative skin damage. A multicenter randomized trial will evaluate its safety and efficacy in reducing dermatitis severity and improving treatment continuity.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special skin cream made from amino acid-based lipids (natural building blocks of protein) to see whether it can prevent or treat radiation dermatitis — the painful skin inflammation, burns, and peeling that commonly occur during radiation therapy for head and neck cancers. **You may be eligible if...** - You have been diagnosed with a non-metastatic (not yet spread) head or neck cancer confirmed by biopsy - You are scheduled to receive high-dose radiation therapy as your primary treatment or after surgery **You may NOT be eligible if...** - You are very unwell and cannot tolerate treatment well (ECOG performance status above 2) - You already have a skin rash, wound, or open sore in the area that will be treated - You have a known allergy to trolamine or amino acids - You have an inflammatory skin condition in the treatment area - You have had prior radiation therapy to the head or neck Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmino acid-derived lipids

Amino acid-derived lipids are applied to the treatment area, once daily during radiotherapy.

BEHAVIORALstandard of care

Standard of care


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT07081074


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