Repair Cream for Preventing Radiation Dermatitis in Breast Cancer
Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer
Recruiting
Phase 3
Interventional Study
Skin Microbiome
Breast Cancer
Radiation Dermatitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 326 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
Who this trial is looking for
This trial is looking for women aged 18 to 70 who have been diagnosed with breast cancer and will be receiving radiotherapy after surgery. Participants will use a special cream to see if it helps prevent skin problems caused by radiation treatment.
Are You a Good Fit for This Trial?
You may be able to join if
- I am aged 18 to 70
- I have been diagnosed with breast cancer
- I will receive radiotherapy after surgery
- I have not had radiotherapy before
- I am in good health to tolerate side effects of treatment
- I will not use other skincare products during the study
- I agree to participate and follow study instructions
You may not be able to join if
- I have had radiotherapy before
- I have severe health issues like heart or kidney problems
- I have a history of other cancers
- I have skin issues in the treatment area
- I am allergic to the study cream or its ingredients
- I am currently in another clinical trial
- I participated in a clinical trial in the last 3 months
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy efficacy. Current pharmacological prophylactic measures clinically employed - inclu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 and \<70 years, with pathologically confirmed breast cancer;
* TNM stage T1-3N1-3M0 or T3-4N0M0;
* Underwent mastectomy with or without implant reconstruction; ④ Medically fit for adjuvant radiotherapy (i.e., in good general condition to tolerate expected side …
Contacts