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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2025-11-23

Brief Summary

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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.

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Detailed Description

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Radiation dermatitis represents one of the most frequent complications in patients with head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) undergoing radiotherapy, often leading to treatment interruption and compromised therapeutic outcomes. To address the limitations of current preventive strategies, this project proposes a novel amino acid-based lipid formulation designed to scavenge reactive oxygen species (ROS). Leveraging FDA-approved natural amino acids and engineered into a unique nanoliposomal structure, this formulation enables efficient delivery of antioxidative agents, effectively neutralizing excess ROS generated during radiotherapy while activating endogenous antioxidant signaling pathways, thereby mitigating oxidative damage to dermal cells. A multicenter randomized controlled clinical trial will be conducted to systematically evaluate the efficacy and safety of this intervention in reducing the incidence and severity of radiation dermatitis. This study will provide a clinically viable and safe prophylactic strategy, enhancing patients' quality of life and ensuring uninterrupted radiotherapy, with significant translational and societal implications.

Conditions

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Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Amino acid-derived lipids

Group Type EXPERIMENTAL

Amino acid-derived lipids

Intervention Type DRUG

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

standard of care

Group Type ACTIVE_COMPARATOR

standard of care

Intervention Type BEHAVIORAL

Standard of care

Interventions

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Amino acid-derived lipids

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

Intervention Type DRUG

standard of care

Standard of care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
2. Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.

Exclusion Criteria

1. Eastern Cooperative Oncology Group performance status of \>2;
2. Pre-existing skin rash, ulceration or open wound in the treatment area;
3. Known allergy to trolamine or amino acid;
4. Inflammatory or connective tissue disorder of the skin;
5. History of head and neck radiotherapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No