Radiation DermatitisNCT07081074
ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer
A study testing Amino acid-derived lipids in people with Radiation Dermatitis, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Dermatitis
- What is being tested?
- Amino acid-derived lipids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2025to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Xingchen Peng, +86 18980606753, pxx2014@163.com
About this study
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.
Read the detailed description
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
- Radiation Dermatitis
- Being tested
- Amino acid-derived lipids, standard of care
- Medical subject headings
- Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acid-derived lipidsDrug
Amino acid-derived lipids are applied to the treatment area, once daily during radiotherapy.
standard of careBehavioural
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Amino acid-derived lipids | Experimental | Not described Receives: Drug: Amino acid-derived lipids |
| standard of care | Active comparator | Not described Receives: Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of radiotherapy to 2 weeks after completion of radiotherapy.
Secondary outcomes (1)
The maximum skin toxicity
The maximum grade of RTOG skin toxicity between 0 and 4.
Measured: From the start of radiotherapy to 2 weeks after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start23 Jul 2025
- Primary completion23 May 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, Sichuan University West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081074
- Sponsor's protocol ID
- 2024-134-3
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT07081074
- Acronym / sponsor ID
- 2024-134-3
- Conditions
- Radiation Dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 23 May 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acid-derived lipids | Experimental | Drug: Amino acid-derived lipids |
| standard of care | Active comparator | Behavioral: standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amino acid-derived lipidsAmino acid-derived lipids are applied to the treatment area, once daily during radiotherapy. | Drug | Amino acid-derived lipids |
| standard of careStandard of care | Behavioural | standard of care |
Primary outcome
The incidence of radiation dermatitis
Time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.
1 secondary outcome
The maximum skin toxicity
Time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingchen Peng principal investigator
Sichuan University West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acid-derived lipids in people with Radiation Dermatitis, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingchen Peng (+8618980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of radiation dermatitis (time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.