Skin-repair cream to prevent radiation dermatitis after breast cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sun Yat-sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chen Dr
• Email: 576503385@qq.com
• Phone: 17620002635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.