The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients
Invasive breast cancer confirmed by pathology
Underwent mastectomy and breast reconstruction
Radiotherapy after breast reconstruction
Disqualifiers
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 population
Breast cancer patients who have underwent mastectomy and breast reconstruction and who will receive post-operative radiotherapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
post-operative radiotherapy
RadiationBreast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Severe radiation dermatitis1 intervention
Group B: No or mild radiation dermatitis1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
3 monthsSecondary 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)
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov