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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joben Bio-Medical Co., Ltd.
• Collaborators: Efficient Pharma Management Corp.; Kaohsiung Medical University Chung-Ho Memorial Hospital; Taipei Veterans General Hospital, Taiwan

Criteria

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.