Overview

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.