Skin-repair cream to prevent radiation dermatitis after breast cancer surgery
Skin Repairing Cream for the Prevention of Radiation Dermatitis and Regulation of Skin Microbial Environment in Breast Cancer: A Multicenter, Prospective, Randomized Controlled Study
This phase 3 trial tests whether a natural weak-acid skin repair cream can prevent acute radiation dermatitis in adults who had mastectomy and are receiving adjuvant radiotherapy for breast cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 326 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07066280 on ClinicalTrials.gov |
What this trial studies
This phase 3 interventional trial compares a natural weak-acid macromolecular/small molecular skin repair cream with a moisturizing cream control in post-operative breast cancer patients undergoing radiotherapy. Eligible participants are adults aged 18–69 who had mastectomy with or without implant reconstruction and are medically fit for adjuvant radiotherapy; they must agree to use only the assigned topical product during the radiotherapy period. The protocol aims to maintain skin surface acidity and modulate cutaneous microecology to reduce the incidence and severity of acute radiation dermatitis, while monitoring safety and tolerability. Outcomes include rates of moderate-to-severe dermatitis, cosmetic impact, quality of life measures, and adverse events.
Who should consider this trial
Good fit: Adults 18–69 with pathologically confirmed breast cancer (specified TNM stages) who underwent mastectomy with or without implant reconstruction and are fit for adjuvant radiotherapy and willing to use only the study topical product are ideal candidates.
Not a fit: Patients with prior radiotherapy, active dermatologic disease in the treatment area, severe systemic illness, immunocompromise, or skin reactions from concurrent systemic therapies are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the cream could lower moderate-to-severe radiation dermatitis rates, improve cosmetic outcomes and quality of life, and help patients complete radiotherapy with fewer complications.
How similar studies have performed: Preliminary and mechanistic studies suggest skin pH and microbiome–targeted approaches may reduce radiation dermatitis, but high-quality phase 3 evidence for this specific cream is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age ≥18 and \<70 years, with pathologically confirmed breast cancer;
* TNM stage T1-3N1-3M0 or T3-4N0M0;
* Underwent mastectomy with or without implant reconstruction; ④ Medically fit for adjuvant radiotherapy (i.e., in good general condition to tolerate expected side effects such as fatigue, nausea, or vomiting); ⑤ No concurrent use of other skincare products throughout the study period;
* Voluntary participation with signed informed consent, agreeing to comply with investigator-directed use of the trial product.
Exclusion Criteria:
* Prior history of radiotherapy;
* Severe systemic diseases (e.g., significant cardiac, hepatic, or renal dysfunction; immunocompromising conditions such as lymphoma, acquired immunodeficiency syndrome \[AIDS\], or Wiskott-Aldrich syndrome) or history of other malignancies; ③ Skin reactions due to systemic therapies (e.g., chemotherapy, immunotherapy) or active dermatologic conditions in the treatment area;
* Known hypersensitivity to the natural weak-acid macromolecular/small molecular repair cream or any of its components; ⑤ Current participation in other clinical trials or participation within the past 3 months, or judged by investigators to have poor compliance that would prevent completion of the study.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Chen Dr
- Email: 576503385@qq.com
- Phone: 17620002635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.