Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients (NCT02289365) | Clinical Trial Compass
UnknownPhase 2
Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients
Taiwan120 participantsStarted 2014-11
Plain-language summary
This trial is designed as a multicenter, double-blinded, randomized, placebo controlled study to assess the safety and efficacy of JBM-TC4 for the prevention and treatment of acute radiation-induced dermatitis in breast cancer patients receiving radiotherapy.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* males or non-pregnant females at least 20 year of age.
* Diagnosis of, non-inflammatory breast adenocarcinoma and be referred for post-operative radiotherapy without concurrent chemotherapy.
* Breast adenocarcinoma previously treated by lumpectomy with or without adjuvant or neoadjuvant chemotherapy or hormonal treatment.
* With in situ breast cancer are also eligible
* Prescribed concurrent hormone treatment with radiation treatment
* Participants must be scheduled to receive 5 sessions of radiotherapy per week (1 session per day) for at least 5 weeks using standard (1.8 Gy to 2.0 Gy per session) for total dose of at least 45 Gy.
* A time period of 3 weeks must elapse after chemotherapy and surgery before beginning this study.
* Must be able to swallow medication.
* Participant must give informed consent.
Exclusion Criteria:
* Bilateral breast cancer
* Previous radiotherapy to the breast or chest.
* Chemotherapy cocurrent with radiation treatment.
* Receiving treatment with anti-coagulants, or anti-human epidermal growth factor receptor drugs, e.g., Iressa (gefitinib), Erbitux (cetuximab, C225), concurrently with their radiotherapy.
* Prior breast reconstructions, implants, and/or expanders.
* Known radiosensitivity syndromes, e.g., Ataxia-telangiectasia.
* Collagen vascular disease, vasculitis, unhealed surgical sites, breast infections, or systemic lupus erythematosus.
* Baseline blood tests that meet the following criteria:
* Grade 2 change in ā¦