Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer

NCT07064577 | Recruiting

• 1 other identifier: 2024-134-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

There is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes and aim to evaluate their effectiveness in preventing radiation dermatitis in patients with head and neck cancer.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• The incidence of grade 2 or higher 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)

ROS-scavenging Nanoenzymes

EXPERIMENTAL

Drug: ROS-scavenging Nanoenzymes

Standard of care

ACTIVE COMPARATOR

Behavioral: Standard of care

Interventions

ROS-scavenging Nanoenzymes DRUG

ROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy.

ROS-scavenging Nanoenzymes

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;
• 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, 610000, 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, Prof.

  Sichuan University West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingchen Peng, Prof.

CONTACT

+86 18980606753; 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 11, 2025
• First Posted: July 14, 2025
• Study Start: July 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 15, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)