Radiation DermatitisNCT05032768
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
An observational study of Radiation Dermatitis and Skin Microbiome, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Radiation Dermatitis, Skin Microbiome, Breast Cancer
- What is being tested?
- post-operative radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who have underwent mastectomy and breast reconstruction and who will receive post-operative radiotherapy.
Who may be able to join
- Female patients
- Invasive breast cancer confirmed by pathology
- Underwent mastectomy and breast reconstruction
- Radiotherapy after breast reconstruction
- ECOG score 0-1
- Signed informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Li Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: 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.
Read the 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.
- Being tested
- post-operative radiotherapy
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-operative radiotherapyRadiation
Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Severe radiation dermatitis | RTOG/EORTC grade 2 and above Receives: Radiation: post-operative radiotherapy | |
| No or mild radiation dermatitis | RTOG/EORTC grade 0 or 1 Receives: Radiation: post-operative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (1)
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)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation DermatitisStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Yu, MD, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032768
- Sponsor's protocol ID
- FDRT-BC015
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients Receiving Radiation After Mastectomy and Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT05032768
- Acronym / sponsor ID
- FDRT-BC015
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe radiation dermatitis | – | Radiation: post-operative radiotherapyRTOG/EORTC grade 2 and above |
| No or mild radiation dermatitis | – | Radiation: post-operative radiotherapyRTOG/EORTC grade 0 or 1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who have underwent mastectomy and breast reconstruction and who will receive post-operative radiotherapy.
Key inclusion criteria (6 listed)
- Female patients
- Invasive breast cancer confirmed by pathology
- Underwent mastectomy and breast reconstruction
- Radiotherapy after breast reconstruction
- ECOG score 0-1
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post-operative radiotherapyBreast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy. | Radiation | No or mild radiation dermatitis, Severe radiation dermatitis |
Primary outcome
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)
1 secondary outcome
Skin microbiome differences between patients with and without >=2 late radiation dermatitis
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, MD contact
Xiaoli Yu, MD, Ph.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Dermatitis and Skin Microbiome, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Shi, MD, Ph.D (+86 18121299680, wei.shi118@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin microbiome differences between patients with and without >=2 acute radiation dermatitis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.