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

NCT07081074 | Recruiting

• 1 other identifier: 2024-134-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• The incidence of radiation dermatitis

  Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.

  From the start of radiotherapy to 2 weeks after completion of radiotherapy.

Secondary Outcomes (1)

• The maximum skin toxicity

  From the start of radiotherapy to 2 weeks after completion of radiotherapy.

Study Arms (2)

Amino acid-derived lipids

EXPERIMENTAL

Drug: Amino acid-derived lipids

standard of care

ACTIVE COMPARATOR

Behavioral: standard of care

Interventions

Amino acid-derived lipids DRUG

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

Amino acid-derived lipids

standard of care BEHAVIORAL

Standard of care

standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of head and neck radiotherapy.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Radiodermatitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Xingchen Peng

  Sichuan University West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng

CONTACT

+8618980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 23, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)