Status:
UNKNOWN
Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients
Lead Sponsor:
Joben Bio-Medical Co., Ltd.
Collaborating Sponsors:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Conditions:
Radiodermatitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 d...
Detailed Description
This study will be conducted in 2 sites in Taiwan. Upon confirmation of meeting all eligibility criteria, will be randomized in a 1:1:1 ratio to 2000 mg or 3000 mg JBM-TC4 oral treatment group or to p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02289365
Start Date
November 1 2014
End Date
December 1 2016
Last Update
June 15 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Departmant of Radiotherapy, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan, 80756
2
Department of Oncology, Taipei Verterans General Hospital
Taipei, Taiwan, Taiwan, 11217
3
Department of Radiation Oncology, China Medical University Hospital
Taichung, Taiwan