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NCT Number: NCT05032768

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients
  • Invasive breast cancer confirmed by pathology
  • Underwent mastectomy and breast reconstruction
  • Radiotherapy after breast reconstruction
  • ECOG score 0-1
  • Signed informed consent

Exclusion criteria

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

Treatment and study plan

Post-Operative Radiotherapy

Radiation

Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.

Primary outcomes

  1. Skin microbiome differences between patients with and without >=2 acute radiation dermatitis

    Time frame: 3 months

    Acute radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)

Secondary outcomes

  1. Skin microbiome differences between patients with and without >=2 late radiation dermatitis

    Time frame: 5 years

    Late radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)

Study contacts

Contact information is provided by the study sponsor or research team.

Li Zhang, MD

CONTACT

[email protected]

Wei Shi, MD, Ph.D

CONTACT

[email protected]

+86 18121299680

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2026
First posted
Sep 2, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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