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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital

About this trial

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 criteria

Qualifiers

Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;

Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.

Disqualifiers

Eastern Cooperative Oncology Group performance status of >2;

Pre-existing skin rash, ulceration or open wound in the treatment area;

Known allergy to trolamine or amino acid;

Inflammatory or connective tissue disorder of the skin;

Trial design

Treatments tested in this trial

  • Amino acid-derived lipids
  • standard of care

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators