The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients

Recruiting

• Conditions: Radiation Dermatitis; Reconstructive Surgery; Skin Microbiome; Breast Cancer
• Interventions: Radiation: post-operative radiotherapy

• Registration Number: NCT05032768
• Lead Sponsor: Fudan University

Brief Summary

The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis.

Detailed Description

Radiotherapy is an important treatment for breast cancer patients. About 95% of patients receiving radiotherapy will develop a degree of radiation dermatitis. Radiation dermatitis is usually limited to the site of radiation treatment. Symptoms vary and can range from itching, burning and pain to open or bleeding ulcers, which can greatly affect the quality of life of patients. Severe acute radiation dermatitis can lead to interruption or delay of treatment. At present, there is no standard for the prevention and treatment of radiation dermatitis. Our skin is home to millions of bacteria, fungi and viruses which compose the skin microbiota. Skin microbiota interacts with skin and affects physiology and immunity of the skin. Previous studies have reported the effects of radiotherapy on skin and immune system. However, so far, no studies have analyzed the effects of radiotherapy on skin microbiome and how skin microbiome affects the skin immune responses after radiotherapy. In this study, the breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis. The long-term goal of this study is to deepen the understanding of the role of skin microbiome in the occurrence and development of radiation dermatitis, and provide a basis for subsequent exploration to reduce radiation dermatitis by regulating skin microecology.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-07-25
• Status Verified: 2021-08
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study First Posted: 2021-09-02
• Last Update Posted: 2021-09-02
• Primary Completion: 2021-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Female patients
2. Invasive breast cancer confirmed by pathology
3. Underwent mastectomy and breast reconstruction
4. Radiotherapy after breast reconstruction
5. ECOG score 0-1
6. Signed informed consent

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Exclusion Criteria

1. Previous breast or chest radiotherapy
2. Other serious skin diseases (systemic lupus erythematosus, skin sclerosis, et al) and cannot receive radiotherapy
3. Pregnant women
4. Patients who are unwilling or unable to receive regular follow-up.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe radiation dermatitis	post-operative radiotherapy	RTOG/EORTC grade 2 and above
No or mild radiation dermatitis	post-operative radiotherapy	RTOG/EORTC grade 0 or 1

Primary Outcome Measures

Name	Time	Method
Skin microbiome differences between patients with and without >=2 acute radiation dermatitis	3 months	Acute radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)

Secondary Outcome Measures

Name	Time	Method
Skin microbiome differences between patients with and without >=2 late radiation dermatitis	5 years	Late radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China