Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer

NCT ID: NCT07066280

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2026-06-30

Brief Summary

Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy efficacy. Current pharmacological prophylactic measures clinically employed - including topical corticosteroids, superoxide dismutase, and trolamine cream - demonstrate suboptimal efficacy and lack high-level evidence-based medical support. Emerging research indicates an association between cutaneous microbial homeostasis and ARD development, suggesting that maintaining skin surface acidity and modulating microecological balance may represent more effective preventive strategies.

This study evaluates the efficacy and safety of a natural weak-acid macromolecular/small molecular repair cream in preventing ARD among post-operative breast cancer patients receiving radiotherapy through skin microbiome modulation. We enrolled 326 high-risk early-stage breast cancer patients scheduled for post-operative radiotherapy and randomized them to compare the superiority of the natural weak-acid repair cream versus conventional care with moisturizer. Concurrent skin microbiome sampling was performed to assess microecological changes and their impact on ARD development. The findings will provide high-level clinical evidence and theoretical basis for the safer and more effective application of this natural weak-acid repair cream in preventing post-radiotherapy ARD in breast cancer patients.

Conditions

Skin Microbiome; Breast Cancer; Radiation Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

Skin Repairing Cream

Intervention Type: DRUG

Skin Repairing Cream containing natural weak-acid

Control group

Group Type: OTHER

Cetaphil® Moisturizing Cream as Inactive Control

Intervention Type: OTHER

Cetaphil® Moisturizing Cream

Interventions

Skin Repairing Cream

Skin Repairing Cream containing natural weak-acid

Intervention Type: DRUG

Cetaphil® Moisturizing Cream as Inactive Control

Cetaphil® Moisturizing Cream

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen Dr

Role: CONTACT

576503385@qq.com

17620002635

Facility Contacts

Chen Dr

Role: primary

576503385@qq.com

+8617620002635

Other Identifiers

SYSKY-2024-1129-01

Identifier Type: -

Identifier Source: org_study_id