Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients

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.

Sex

All

Minimum age

20 Years

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 hemoglobin (i.e., 25% decease from baseline);
  * Grade 1 change in platelets (i.e., \< 75'000/mm3);
  * Grade 2 change in prothrombin time and partial thromboplastin time (i.e., 1.5-2x upper limit of normal);
  * Grade 1 change in aspartate transaminase, alanine transaminase (i.e., \> 2.5x upper limit of normal);
  * Grade 1 change in bilirubin (i.e., \> 1.5x upper limit of normal);
  * Grade 1 change in Creatinine (i.e., \> 2x upper limit of normal).
* Conditions affecting the absorption for oral medications.

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