Clinical Trials List
Protocol NumberJBM-001
2014-12-20 - 2018-03-31
Phase II
Terminated3
ICD-10L58.9
Radiodermatitis, unspecified
ICD-9692.82
Dermatitis due to other radiation
Phase 2 Study of Orally Administrated JBM-TC4 for the Prevention of Acute Radiation-induced Dermatitis in Breast Cancer Patients
-
Sponsor
Joben Bio-Medical
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Yii Huang Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yao-Ching Wang Division of Radiation Therapy
- Chih-Jung Chen Division of General Surgery
- Shang-Wen Chen Division of Radiation Therapy
- Liang-Chih Liu Division of General Surgery
- Ying-Chun Lin Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Acute Radiation-induced Dermatitis
Objectives
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.
Test Drug
JBM-TC4 Capsule
Active Ingredient
JBM-TC4
Dosage Form
Capsules
Dosage
500
Endpoints
Primary Outcome Measures :
Radiation Dermatitis Severity Scale (RDS) [ Time Frame: baseline to 92 days ]
During each weekly visit (Day 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86 and 92), starting from baseline evaluation at Day 0, the severity of radiodermatitis in breast cancer patients at the radiotherapy site will be assess by the investigator using the RDS (CTCAE 4.03), which the ranges from 0 to 5 with increments of 1.
Secondary Outcome Measures :
Presence of Moist Desquamation [ Time Frame: baseline to 92 days ]
The presence of moist desquamation information will be obtained from RDS score at 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86, 92 days. Patients with score 3 or more will be recorded as having moist desquamation on the radiotherapy site.
Redness Scale [ Time Frame: baseline to 92 days ]
Score of redness at the radiotherapy site will be evaluated at all the visits starting from Day 0 along with RDS scale (at 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86, 92 days).
Worst Pain Related to Radiodermatitis at the site [ Time Frame: baseline to 92 days ]
Starting on Day 0, patients will be ask to circle a number that best describe the worst pain related to dermatitis they have been experiencing through the past week. (at 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86, 92 days)
Improve Quality of Life [ Time Frame: 92 days ]
Quality of life is measured using the Quality of Life Questionnaire. Patients will select the response that best describe their conditions at Day 0, 29, 57, 85 and 92. Scores will be calculated ans transcribed scores will be collected on the case report forms.
Vital sign [ Time Frame: baseline to 92 days ]
Blood pressure and pulse rate will be measured in the writing arm and recorded to mmHg or beat per minute, respectively. The same arm will be used through this study. They will be measured after 5 minutes supine and 2 minutes standing. Oral temperature, recorded to the nearest 0.1 degree Celsius, will be measured during the supine vital sign measurements. All above will be obtained at Day 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86 and 92.
Electrocardiogram [ Time Frame: baseline to 85 days ]
A 12-lead ECG will be obtained on all subjects at the designed times (Fay 0, 8, 29, 57 and 85) in the flow charts.
Hematology and Serology test [ Time Frame: baseline to 92 days ]
During the visits on Days 0, 29, 57, 85 and 92, the blood samples will be drawn for routine laboratory evaluations. The parameters includes hemoglobin, hematocrit, white blood count with differential, platelet count, red blood cell count, Glutamate-oxaloacetate transaminase, Glutamic-Pyruvic Transaminase, blood urea nitrogen, creatinine, cholesterol, HDL, LDL, triglyceride, blood glucose test.. Plasma sample will be collected and frozen at visits days 0, 8 (after ECG collection), 29, 57 and 85 for future assay of pharmacokinetics.
Occurrence of Adverse Events [ Time Frame: up to 92 days ]
All adverse events, regardless of seriousness, severity, or presumed relationship to study drug, are events that occur between the day of with the informed consent is signed and completion of the treatment phase. They must be recorded using medical terminology in the source document and the Case Report Form. Graphical techniques may also be used to examine the relationship between these measures and dose and to investigate any trends in the data. Incidence rates for all adverse events , and the number of subjects withdrawing from the study for each reason will be tabulated.
Radiation Dermatitis Severity Scale (RDS) [ Time Frame: baseline to 92 days ]
During each weekly visit (Day 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86 and 92), starting from baseline evaluation at Day 0, the severity of radiodermatitis in breast cancer patients at the radiotherapy site will be assess by the investigator using the RDS (CTCAE 4.03), which the ranges from 0 to 5 with increments of 1.
Secondary Outcome Measures :
Presence of Moist Desquamation [ Time Frame: baseline to 92 days ]
The presence of moist desquamation information will be obtained from RDS score at 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86, 92 days. Patients with score 3 or more will be recorded as having moist desquamation on the radiotherapy site.
Redness Scale [ Time Frame: baseline to 92 days ]
Score of redness at the radiotherapy site will be evaluated at all the visits starting from Day 0 along with RDS scale (at 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86, 92 days).
Worst Pain Related to Radiodermatitis at the site [ Time Frame: baseline to 92 days ]
Starting on Day 0, patients will be ask to circle a number that best describe the worst pain related to dermatitis they have been experiencing through the past week. (at 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86, 92 days)
Improve Quality of Life [ Time Frame: 92 days ]
Quality of life is measured using the Quality of Life Questionnaire. Patients will select the response that best describe their conditions at Day 0, 29, 57, 85 and 92. Scores will be calculated ans transcribed scores will be collected on the case report forms.
Vital sign [ Time Frame: baseline to 92 days ]
Blood pressure and pulse rate will be measured in the writing arm and recorded to mmHg or beat per minute, respectively. The same arm will be used through this study. They will be measured after 5 minutes supine and 2 minutes standing. Oral temperature, recorded to the nearest 0.1 degree Celsius, will be measured during the supine vital sign measurements. All above will be obtained at Day 0,8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 86 and 92.
Electrocardiogram [ Time Frame: baseline to 85 days ]
A 12-lead ECG will be obtained on all subjects at the designed times (Fay 0, 8, 29, 57 and 85) in the flow charts.
Hematology and Serology test [ Time Frame: baseline to 92 days ]
During the visits on Days 0, 29, 57, 85 and 92, the blood samples will be drawn for routine laboratory evaluations. The parameters includes hemoglobin, hematocrit, white blood count with differential, platelet count, red blood cell count, Glutamate-oxaloacetate transaminase, Glutamic-Pyruvic Transaminase, blood urea nitrogen, creatinine, cholesterol, HDL, LDL, triglyceride, blood glucose test.. Plasma sample will be collected and frozen at visits days 0, 8 (after ECG collection), 29, 57 and 85 for future assay of pharmacokinetics.
Occurrence of Adverse Events [ Time Frame: up to 92 days ]
All adverse events, regardless of seriousness, severity, or presumed relationship to study drug, are events that occur between the day of with the informed consent is signed and completion of the treatment phase. They must be recorded using medical terminology in the source document and the Case Report Form. Graphical techniques may also be used to examine the relationship between these measures and dose and to investigate any trends in the data. Incidence rates for all adverse events , and the number of subjects withdrawing from the study for each reason will be tabulated.
Inclution 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.
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
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.
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.
The Estimated Number of Participants
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Taiwan
120 participants
-
Global
0 participants
