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

The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients Receiving Radiation After Mastectomy and Reconstructive Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiation Dermatitis; Skin Microbiome; Reconstructive Surgery
• Intervention / Treatment: Radiation: post-operative radiotherapy

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Wei Shi, MD, Ph.D; Phone Number: +86 18121299680; Email: wei.shi118@foxmail.com
• Study Contact Backup: Name: Li Zhang, MD; Email: zhangliaaa111@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients who have underwent mastectomy and breast reconstruction and who will receive post-operative radiotherapy.

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Severe radiation dermatitis; RTOG/EORTC grade 2 and above	Radiation: post-operative radiotherapy; Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.
No or mild radiation dermatitis; RTOG/EORTC grade 0 or 1	Radiation: post-operative radiotherapy; Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Xiaoli Yu, MD, Ph.D, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Radiation Injuries; Breast Neoplasms; Dermatitis; Radiodermatitis
• Other Study ID Numbers: FDRT-BC015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No