Acute Radiation DermatitisNCT07380230

Efficacy and Safety of Qibei Jiedu Formula for Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients

A study testing Standard Basic Treatment Combined with Qibei Jiedu Formula and Standard Basic Treatment Combined with Qibei Jiedu Formula simulator in people with Acute Radiation Dermatitis and Traditional Chinese Medicine (TCM), run by LI FENG at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

1. To evaluate the preventive and therapeutic effects of Qibei Jiedu Formula on acute radiation dermatitis in breast cancer patients, including the incidence of grade 2 or higher radiation dermatitis, wound healing time, and symptom relief. 2. To observe the safety profile of Qibei Jiedu Formula. 3. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Acute Radiation Dermatitis, Traditional Chinese Medicine (TCM), Breast Cancer
What is being tested?: Standard Basic Treatment Combined with Qibei Jiedu Formula and Standard Basic Treatment Combined with Qibei Jiedu Formula simulator
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 27 Jan 2026to 31 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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with pathologically confirmed unilateral stage I-III non-inflammatory breast cancer, having undergone breast-conserving surgery or modified radical mastectomy, and having received or planned to receive standard adjuvant therapy according to current clinical guidelines.
Scheduled to receive postoperative adjuvant radiotherapy using a hypofractionated regimen (40-50 Gy/15 fractions) as recommended by the NCCN Breast Cancer Guidelines and the CSCO Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition).
Meeting the TCM diagnostic criteria for the syndrome of Qi-Yin Deficiency with Blood Stasis and Toxin Accumulation.
Karnofsky Performance Status (KPS) score ≥70.
Age ≥18 years, female.
Voluntarily participating in the study and providing written informed consent.

Who cannot join

Presence of grade 4 radiation dermatitis requiring urgent intervention at enrollment or during the study.
Prior radiotherapy to the breast or chest within the past 3 months.
Any skin condition that may interfere with the assessment of radiation dermatitis, such as active infection, atopic dermatitis, psoriasis, vitiligo, active collagen vascular disease (e.g., scleroderma, lupus erythematosus), or other known autoimmune disorders significantly altering skin appearance or physiological response.
Pre-existing grade ≥2 hepatic/renal dysfunction or hematological toxicity (according to CTCAE v5.0 criteria) before treatment.
Concurrent participation in other clinical trials or concurrent use of other Chinese herbal preparations.
Unstable mental status or inability to cooperate with the study procedures.
Pregnant or lactating patients.
Known allergy to any component of the herbal formula used in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Feng, Doctor contact

Yirui Yan contact

China1 site

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Efficacy and Safety of Qibei Jiedu Formula Versus Placebo in Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients: A Prospective, Double-blind, Randomized Controlled Trial

To evaluate the preventive and therapeutic effects of Qibei Jiedu Formula on acute radiation dermatitis in breast cancer patients, including the incidence of grade 2 or higher radiation dermatitis, wound healing time, and symptom relief.
To observe the safety profile of Qibei Jiedu Formula.
To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life.
To explore the potential mechanism of action of Qibei Jiedu Formula in preventing and treating acute radiation dermatitis in breast cancer patients through exploratory indicators such as inflammatory cytokines and skin microbiota.
This study is a small-scale exploratory clinical trial. It aims to collect preliminary efficacy and safety data from 60 participants to assess the "add-on effect" of Qibei Jiedu Formula on top of "standard basic care". The results are intended for estimating effect sizes and generating hypotheses to inform future large-scale studies, not for drawing definitive conclusions.

Read the detailed description

Acute Radiation Dermatitis (ARD) following breast cancer radiotherapy has an incidence rate as high as 95%, with grade 3 or higher dermatitis leading to unplanned radiotherapy interruption in 15-20% of patients. This not only compromises treatment efficacy but also significantly impairs patients' quality of life. Current conventional Western medical management primarily relies on corticosteroids and moisturizers, yet faces limitations in efficacy and notable side effects. Developed based on the Fuzheng Quyu Jiedu (Strengthening Vital Qi, Removing Stasis, and Detoxifying) theory, the Qibei Jiedu Formula has shown promising anti-inflammatory, antipruritic, and wound-healing effects in preliminary clinical observations.

Led by Professor Feng Li's team from the Cancer Hospital of the Chinese Academy of Medical Sciences, this project adopts a multicenter, randomized, double-blind, placebo-controlled clinical trial design. It plans to enroll 60 breast cancer patients scheduled for radiotherapy to systematically evaluate the clinical efficacy and safety of Qibei Jiedu Formula in preventing and treating ARD. The study aims to provide high-level evidence-based medical data for the integrated Chinese and Western medicine prevention and management of ARD. Furthermore, it seeks to establish a safer and more effective treatment regimen, thereby reducing unplanned radiotherapy interruptions and improving oncologic outcomes. The findings are expected to offer an evidence-based rationale for the TCM-based prevention and treatment of radiation dermatitis, provide a new option for clinical practice, and contribute positively to enhancing the quality of life of cancer patients, holding significant social value.

Conditions: Acute Radiation Dermatitis, Traditional Chinese Medicine (TCM), Breast Cancer
Being tested: Standard Basic Treatment Combined with Qibei Jiedu Formula, Standard Basic Treatment Combined with Qibei Jiedu Formula simulator
Keywords: Acute radiation dermatitis, Integrated Traditional Chinese and Western Medicine, Breast Cancer, Traditional Chinese Medicine
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard Basic Treatment Combined with Qibei Jiedu FormulaDrug
Participants will commence administration of either the Qibei Jiedu Formula on the first day of radiotherapy. The daily regimen consists of one decocted dose, divided into two sealed bags (specification: 100 mL per bag). One bag is to be taken orally twice daily (morning and evening) for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).
Standard Basic Treatment Combined with Qibei Jiedu Formula simulatorDrug
Participants will begin taking either the simulator (containing 5% of the original formula dosage) on the first day of radiotherapy. The daily dose consists of one formula unit, decocted and divided into two bags of medicinal liquid (specification: 100 mL per bag). Participants are to take one bag per dose, twice daily (morning and evening), for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).

Study groups in NCT07380230
Study group	Role	What they receive
Treatment Group	Experimental	Standard basic treatment + Qibei Jiedu Formula Receives: Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula
Control Group	Experimental	Standard basic treatment + Qibei Jiedu Formula simulator (containing 5% of the original formula dosage) Receives: Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula simulator

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Grade ≥2 Acute Radiation Dermatitis
The proportion of participants who develop Grade 2 or higher acute radiation dermatitis during radiotherapy and within 1 month after completion of radiotherapy, as assessed and confirmed by investigators according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)

Secondary outcomes (7)

Time to Onset of Grade 2 Acute Radiation Dermatitis
Time from the start of radiotherapy to the first occurrence of Grade 2 acute radiation dermatitis, as confirmed by investigators according to CTCAE v5.0.
Measured: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Time to Wound Healing of Radiation Dermatitis
Time from the first documented occurrence of Grade 2 or 3 acute radiation dermatitis to recovery to less than Grade 2 (Grade 0 or 1), as assessed according to CTCAE v5.0 and the Guidelines for Clinical Research of New Chinese Medicines.
Measured: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Severity of Radiation Dermatitis Symptoms Assessed by RISRAS
Severity of radiation-induced skin reactions assessed using the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).
RISRAS is a composite scale consisting of:a patient-reported symptom score (pain, itching, burning, and impact on daily activities), and a clinician-rated skin reaction score.
Scale Range and Interpretation： Total score range: 0 to 36 Higher scores indicate more severe radiation-induced skin reactions
Measured: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Quality of Life Assessed by EORTC QLQ-BR23
Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23).
Scale Range and Interpretation Scores are linearly transformed to a scale of 0 to 100 Higher scores indicate better quality of life or higher symptom burden, depending on the specific subscale, according to the EORTC scoring manual
Measured: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Dermatology-related quality of life assessed using the Dermatology Life Quality Index (DLQI).
Scale Range and Interpretation Total score range: 0 to 30 Higher scores indicate greater impairment of dermatology-related quality of life
Measured: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Traditional Chinese Medicine (TCM) Syndrome Score
Severity of Traditional Chinese Medicine (TCM) syndrome assessed using a composite TCM syndrome score scale developed according to the Guidelines for Clinical Research of New Chinese Medicines (2002 edition), the Guidelines for Diagnosis and Treatment of Malignant Tumors in Traditional Chinese Medicine, and External Treatment of Traditional Chinese Medicine.
The scale evaluates TCM-related symptoms including fatigue, chest tightness and shortness of breath, heat sensations in the palms and soles, dry mouth and throat, localized pain, skin changes, fever with sweating, irritability and insomnia, lip and nail color changes, subcutaneous ecchymosis, dark urine, and constipation.
Treatment efficacy is evaluated based on changes in the total TCM syndrome score from baseline at different assessment time points.
Scale Range and Interpretation Total score range: 0 to 54 Higher scores indicate more severe TCM syndrome symptoms
Measured: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Skin Colorimetric Changes Assessed by Skin Reflectance Spectrophotometry (SRS)
Skin color changes of radiation dermatitis assessed using skin reflectance spectrophotometry with a validated colorimeter. Measurements are performed on the irradiated breast skin, with three readings averaged per site. Skin color is quantified using the CIE L*a*b* color space, and changes from baseline (ΔL*, Δa*, Δb*) are analyzed. Lower ΔL* values indicate increased pigmentation, and higher Δa* values indicate increased erythema severity. Δb* is analyzed as a secondary parameter. Measurements of the contralateral breast are performed at baseline and at the end of radiotherapy to control for systemic skin color changes.
Measured: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 202631 Dec 2026

First posted2 Feb 2026
Study start27 Jan 2026 (estimated)
Primary completion30 Nov 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Acute Radiation DermatitisStudies of the same condition, open and under way.
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
Model description: Standard Basic Treatment: All patients will receive guideline-based hypofractionated radiotherapy (40-50 Gy/15 fractions) and routine skin care (e.g., hydrogel dressings or creams) determined by the treating physician. The specific products and usage must be documented in the CRF and maintained as stable as possible after enrollment. Add-on Intervention: Patients will be randomly assigned to receive either Qibei Jiedu Formula or its simulator (5% of the original formula dosage), taken from the first day of radiotherapy. One decocted dose (divided into two 100-mL bags) is taken twice daily for 21 days (synchronized with radiotherapy).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07380230
Sponsor's protocol ID: 25/468-5594
Status last verified: Jan 2026
First submitted: 19 Jan 2026
Last updated: 2 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Schmeel LC, Koch D, Schmeel FC, Bucheler B, Leitzen C, Mahlmann B, Kunze D, Heimann M, Bruser D, Abramian AV, Schoroth F, Mudder T, Rohner F, Garbe S, Baumert BG, Schild HH, Wilhelm-Buchstab TM. Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment. Polymers (Basel). 2019 Dec 16;11(12):2112. doi: 10.3390/polym11122112.
PubMed 31888185
Bohner AMC, Koch D, Schmeel FC, Rohner F, Schoroth F, Sarria GR, Abramian AV, Baumert BG, Giordano FA, Schmeel LC. Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric L*a*b Color-Space. Cancers (Basel). 2020 Aug 28;12(9):2444. doi: 10.3390/cancers12092444.
PubMed 32872216
Dejonckheere CS, Layer JP, Sarria GR, Wiegreffe S, Glasmacher AR, Nour Y, Scafa D, Mudder T, Anzbock T, Giordano FA, Stope MB, Schmeel LC, Gkika E. Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: study protocol for a phase 3 randomised double-blind placebo-controlled trial (NIPP-RD III). Trials. 2025 Mar 19;26(1):97. doi: 10.1186/s13063-025-08806-w.
PubMed 40108640
Tang Y, Zhou Y, Li HJ. Advances in mesenchymal stem cell exosomes: a review. Stem Cell Res Ther. 2021 Jan 19;12(1):71. doi: 10.1186/s13287-021-02138-7.
PubMed 33468232
Wickenheisser VA, Zywot EM, Rabjohns EM, Lee HH, Lawrence DS, Tarrant TK. Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. Curr Allergy Asthma Rep. 2019 Jul 2;19(8):37. doi: 10.1007/s11882-019-0869-z.
PubMed 31267251
Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH. Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl). 2009 Nov;18(6):636-41. doi: 10.1111/j.1365-2354.2008.00971.x. Epub 2009 Apr 23.
PubMed 19456848
Liu C, Wei J, Wang X, Zhao Q, Lv J, Tan Z, Xin Y, Jiang X. Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection. Front Cell Dev Biol. 2024 Oct 9;12:1480571. doi: 10.3389/fcell.2024.1480571. eCollection 2024.
PubMed 39450273
Rube CE, Freyter BM, Tewary G, Roemer K, Hecht M, Rube C. Radiation Dermatitis: Radiation-Induced Effects on the Structural and Immunological Barrier Function of the Epidermis. Int J Mol Sci. 2024 Mar 15;25(6):3320. doi: 10.3390/ijms25063320.
PubMed 38542294
Xie Y, Wang Q, Hu T, Chen R, Wang J, Chang H, Cheng J. Risk Factors Related to Acute Radiation Dermatitis in Breast Cancer Patients After Radiotherapy: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Nov 29;11:738851. doi: 10.3389/fonc.2021.738851. eCollection 2021.
PubMed 34912704
Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
PubMed 39036382
Giaquinto AN, Sung H, Miller KD, Kramer JL, Newman LA, Minihan A, Jemal A, Siegel RL. Breast Cancer Statistics, 2022. CA Cancer J Clin. 2022 Nov;72(6):524-541. doi: 10.3322/caac.21754. Epub 2022 Oct 3.
PubMed 36190501

Interested in taking part?

Li Feng, Doctor

+86-87788030

fengli663@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Acute Radiation Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Qibei Jiedu Formula Versus Placebo in Preventing and Managing Acute Radiation Dermatitis in Breast Cancer Patients: A Prospective, Double-blind, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07380230
Acronym / sponsor ID: 25/468-5594
Conditions: Acute Radiation Dermatitis, Traditional Chinese Medicine (TCM), Breast Cancer
Keywords: Acute radiation dermatitis, Integrated Traditional Chinese and Western Medicine, Breast Cancer, Traditional Chinese Medicine
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: LI FENGUniversity, hospital or other
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study start: 27 Jan 2026 (estimated)
Primary completion: 30 Nov 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 2 Feb 2026 (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.

To evaluate the preventive and therapeutic effects of Qibei Jiedu Formula on acute radiation dermatitis in breast cancer patients, including the incidence of grade 2 or higher radiation dermatitis, wound healing time, and symptom relief.
To observe the safety profile of Qibei Jiedu Formula.
To investigate the potential role of Qibei Jiedu Formula in improving patients' quality of life.
To explore the potential mechanism of action of Qibei Jiedu Formula in preventing and treating acute radiation dermatitis in breast cancer patients through exploratory indicators such as inflammatory cytokines and skin microbiota.
This study is a small-scale exploratory clinical trial. It aims to collect preliminary efficacy and safety data from 60 participants to assess the "add-on effect" of Qibei Jiedu Formula on top of "standard basic care". The results are intended for estimating effect sizes and generating hypotheses to inform future large-scale studies, not for drawing definitive conclusions.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Standard Basic Treatment: All patients will receive guideline-based hypofractionated radiotherapy (40-50 Gy/15 fractions) and routine skin care (e.g., hydrogel dressings or creams) determined by the treating physician. The specific products and usage must be documented in the CRF and maintained as stable as possible after enrollment. Add-on Intervention: Patients will be randomly assigned to receive either Qibei Jiedu Formula or its simulator (5% of the original formula dosage), taken from the first day of radiotherapy. One decocted dose (divided into two 100-mL bags) is taken twice daily for 21 days (synchronized with radiotherapy).

Arm	Type	Receives
Treatment Group	Experimental	Drug: Standard Basic Treatment Combined with Qibei Jiedu FormulaStandard basic treatment + Qibei Jiedu Formula
Control Group	Experimental	Drug: Standard Basic Treatment Combined with Qibei Jiedu Formula simulatorStandard basic treatment + Qibei Jiedu Formula simulator (containing 5% of the original formula dosage)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with pathologically confirmed unilateral stage I-III non-inflammatory breast cancer, having undergone breast-conserving surgery or modified radical mastectomy, and having received or planned to receive standard adjuvant therapy according to current clinical guidelines.
Scheduled to receive postoperative adjuvant radiotherapy using a hypofractionated regimen (40-50 Gy/15 fractions) as recommended by the NCCN Breast Cancer Guidelines and the CSCO Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition).
Meeting the TCM diagnostic criteria for the syndrome of Qi-Yin Deficiency with Blood Stasis and Toxin Accumulation.
Karnofsky Performance Status (KPS) score ≥70.
Age ≥18 years, female.

Key exclusion criteria (8 listed)

Presence of grade 4 radiation dermatitis requiring urgent intervention at enrollment or during the study.
Prior radiotherapy to the breast or chest within the past 3 months.
Any skin condition that may interfere with the assessment of radiation dermatitis, such as active infection, atopic dermatitis, psoriasis, vitiligo, active collagen vascular disease (e.g., scleroderma, lupus erythematosus), or other known autoimmune disorders significantly altering skin appearance or physiological response.
Pre-existing grade ≥2 hepatic/renal dysfunction or hematological toxicity (according to CTCAE v5.0 criteria) before treatment.
Concurrent participation in other clinical trials or concurrent use of other Chinese herbal preparations.

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
Standard Basic Treatment Combined with Qibei Jiedu FormulaParticipants will commence administration of either the Qibei Jiedu Formula on the first day of radiotherapy. The daily regimen consists of one decocted dose, divided into two sealed bags (specification: 100 mL per bag). One bag is to be taken orally twice daily (morning and evening) for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).	Drug	Treatment Group
Standard Basic Treatment Combined with Qibei Jiedu Formula simulatorParticipants will begin taking either the simulator (containing 5% of the original formula dosage) on the first day of radiotherapy. The daily dose consists of one formula unit, decocted and divided into two bags of medicinal liquid (specification: 100 mL per bag). Participants are to take one bag per dose, twice daily (morning and evening), for a continuous period of 3 weeks (21 days, synchronized with the radiotherapy course).	Drug	Control Group

Primary outcome

Incidence of Grade ≥2 Acute Radiation Dermatitis
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
The proportion of participants who develop Grade 2 or higher acute radiation dermatitis during radiotherapy and within 1 month after completion of radiotherapy, as assessed and confirmed by investigators according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

7 secondary outcomes

Time to Onset of Grade 2 Acute Radiation Dermatitis
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Time to Wound Healing of Radiation Dermatitis
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Severity of Radiation Dermatitis Symptoms Assessed by RISRAS
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)
Quality of Life Assessed by EORTC QLQ-BR23
Time frame: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Quality of Life Assessed by Dermatology Life Quality Index (DLQI)
Time frame: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Traditional Chinese Medicine (TCM) Syndrome Score
Time frame: Baseline, during treatment (Day 14 and Day 21), and 1 month after treatment (Day 49)
Skin Colorimetric Changes Assessed by Skin Reflectance Spectrophotometry (SRS)
Time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)

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 2 Feb 2026.
Background: PubMed 31888185Schmeel LC, Koch D, Schmeel FC, Bucheler B, Leitzen C, Mahlmann B, Kunze D, Heimann M, Bruser D, Abramian AV, Schoroth F, Mudder T, Rohner F, Garbe S, Baumert BG, Schild HH, Wilhelm-Buchstab TM. Hydrofilm Polyurethane Films Reduce Radiation Dermatitis Severity in Hypofractionated Whole-Breast Irradiation: An Objective, Intra-Patient Randomized Dual-Center Assessment. Polymers (Basel). 2019 Dec 16;11(12):2112. doi: 10.3390/polym11122112.
Background: PubMed 32872216Bohner AMC, Koch D, Schmeel FC, Rohner F, Schoroth F, Sarria GR, Abramian AV, Baumert BG, Giordano FA, Schmeel LC. Objective Evaluation of Risk Factors for Radiation Dermatitis in Whole-Breast Irradiation Using the Spectrophotometric L*a*b Color-Space. Cancers (Basel). 2020 Aug 28;12(9):2444. doi: 10.3390/cancers12092444.
Background: PubMed 40108640Dejonckheere CS, Layer JP, Sarria GR, Wiegreffe S, Glasmacher AR, Nour Y, Scafa D, Mudder T, Anzbock T, Giordano FA, Stope MB, Schmeel LC, Gkika E. Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: study protocol for a phase 3 randomised double-blind placebo-controlled trial (NIPP-RD III). Trials. 2025 Mar 19;26(1):97. doi: 10.1186/s13063-025-08806-w.
Background: PubMed 33468232Tang Y, Zhou Y, Li HJ. Advances in mesenchymal stem cell exosomes: a review. Stem Cell Res Ther. 2021 Jan 19;12(1):71. doi: 10.1186/s13287-021-02138-7.
Background: PubMed 31267251Wickenheisser VA, Zywot EM, Rabjohns EM, Lee HH, Lawrence DS, Tarrant TK. Laser Light Therapy in Inflammatory, Musculoskeletal, and Autoimmune Disease. Curr Allergy Asthma Rep. 2019 Jul 2;19(8):37. doi: 10.1007/s11882-019-0869-z.
Background: PubMed 19456848Hong JP, Lee SW, Song SY, Ahn SD, Shin SS, Choi EK, Kim JH. Recombinant human epidermal growth factor treatment of radiation-induced severe oral mucositis in patients with head and neck malignancies. Eur J Cancer Care (Engl). 2009 Nov;18(6):636-41. doi: 10.1111/j.1365-2354.2008.00971.x. Epub 2009 Apr 23.
Background: PubMed 39450273Liu C, Wei J, Wang X, Zhao Q, Lv J, Tan Z, Xin Y, Jiang X. Radiation-induced skin reactions: oxidative damage mechanism and antioxidant protection. Front Cell Dev Biol. 2024 Oct 9;12:1480571. doi: 10.3389/fcell.2024.1480571. eCollection 2024.
Background: PubMed 38542294Rube CE, Freyter BM, Tewary G, Roemer K, Hecht M, Rube C. Radiation Dermatitis: Radiation-Induced Effects on the Structural and Immunological Barrier Function of the Epidermis. Int J Mol Sci. 2024 Mar 15;25(6):3320. doi: 10.3390/ijms25063320.
Background: PubMed 34912704Xie Y, Wang Q, Hu T, Chen R, Wang J, Chang H, Cheng J. Risk Factors Related to Acute Radiation Dermatitis in Breast Cancer Patients After Radiotherapy: A Systematic Review and Meta-Analysis. Front Oncol. 2021 Nov 29;11:738851. doi: 10.3389/fonc.2021.738851. eCollection 2021.
Background: PubMed 39036382Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.
Background: PubMed 36190501Giaquinto AN, Sung H, Miller KD, Kramer JL, Newman LA, Minihan A, Jemal A, Siegel RL. Breast Cancer Statistics, 2022. CA Cancer J Clin. 2022 Nov;72(6):524-541. doi: 10.3322/caac.21754. Epub 2022 Oct 3.
Individual participant dataSharing planned: No

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Radiation-Induced Skin Injury

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.

Li Feng, Doctor contact

Yirui Yan contact

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Feb 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 Li Feng, Doctor (+86-87788030, fengli663@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Grade ≥2 Acute Radiation Dermatitis (time frame: During treatment (Day 7, Day 14, Day 17, Day 21) and 1 month after treatment (Day 49)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07380230, which also lists 11 linked publications.

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 2 Feb 2026.