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

Sponsor

Joben Bio-Medical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02289365

Collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital (Other), Taipei Veterans General Hospital, Taiwan (Other), Efficient Pharma Management Corp. (Industry)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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 dermatitis in breast cancer patients receiving radiotherapy.

Condition or Disease	Intervention/Treatment	Phase
Radiodermatitis	Drug: 2000 mg of JBM-TC4 per day Drug: 3000 mg of JBM-TC4 per day Drug: 3000 mg of PEG-400 per day	Phase 2

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 placebo control group.

The treatment will start one week prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks of JBM-TC4. The patients will take 3 treatment capsules twice a day, after breakfast and dinner. Screening visit will occur up to 14 days prior to randomization (Day 0), and informed consent form will be signed and patient eligibility criteria will be verified.Medical history information, chemistry/hematology evaluation, serum pregnancy will be conducted and documented. On Day 0, baseline assessment will be done and study drug will be dispensed. The patients will be instructed to start their study medication after breakfast on Day 1 and record the administration time in the study diary. Post-operative radiotherapy will begin for all patients after taking the treatment for 7 days. On Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85 and 92, data including radiation dermatitis severity, redness and pain scale will be collected when patients return to the clinic for evaluation. On Days 29, 57, 85 and 92, quality of life questionnaire will be completed by patients and blood will be drawn for chemistry/hematology evaluation. The final study visit will occur one week after the last dose of study medication, which will be around Day 92. ECG will be evaluated on Day 8 and 92. A total of 120 women with breast cancer will be recruited into this study. Safety will be assessed through recording of adverse events, assessment of vital signs, and chemistry/hematology laboratory testing. During each clinic visit, investigator will take down the vital signs of the patients and ask if the patients has experienced any adverse events. All information will be recorded on the case report form.

The primary efficacy endpoint in this study is to assess the effectiveness of JBM-TC4 for the prevention and treatment of acute radiation-induced dermatitis. The effectiveness will be determined by the recording of the radiation dermatitis severity scale for patients during each weekly study visit. Secondary efficacy endpoint include 1) Presence of moist desquamation and 2) redness at the radiation treated site at any visit. 3)The worst pain related to dermatitis between baseline and follow-up visit at the radiotherapy site. 4) Quality of life and 5) safety evaluation assessment. At the final visit, each investigator will be ask to rate their patients' responses to treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Phase 2 Study of Orally Administrated JBM-TC4 for the Prevention of Acute Radiation-induced Dermatitis in Breast Cancer Patients

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group I Totally 3000 mg of PEG-400 per day. 3 capsules of 500 mg PEG-400 per time, twice a day.	Drug: 3000 mg of PEG-400 per day 3 capsules of 500 mg polyethylene glycol 400 (PEG-400), oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.
Experimental: Group II Totally 2000 mg of JBM-TC4 per day. 2 capsules of 500 mg JBM-TC4 plus 1 capsule of 500 mg PEG-400 per time, twice a day.	Drug: 2000 mg of JBM-TC4 per day 2 capsules of 500 mg JBM-TC4 plus 1 capsule of 500 mg PEG-400, oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.
Experimental: Group III Totally 3000 mg of JBM-TC4 per day. 3 capsules of 500 mg JBM-TC4 per time, twice a day.	Drug: 3000 mg of JBM-TC4 per day 3 capsules of 500 mg JBM-TC4, oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.

Arm

Intervention/Treatment

Placebo Comparator: Group I

Totally 3000 mg of PEG-400 per day. 3 capsules of 500 mg PEG-400 per time, twice a day.

Drug: 3000 mg of PEG-400 per day

3 capsules of 500 mg polyethylene glycol 400 (PEG-400), oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.

Experimental: Group II

Totally 2000 mg of JBM-TC4 per day. 2 capsules of 500 mg JBM-TC4 plus 1 capsule of 500 mg PEG-400 per time, twice a day.

Drug: 2000 mg of JBM-TC4 per day

2 capsules of 500 mg JBM-TC4 plus 1 capsule of 500 mg PEG-400, oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.

Experimental: Group III

Totally 3000 mg of JBM-TC4 per day. 3 capsules of 500 mg JBM-TC4 per time, twice a day.

Drug: 3000 mg of JBM-TC4 per day

3 capsules of 500 mg JBM-TC4, oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.

Outcome Measures

Primary Outcome Measures

Radiation Dermatitis Severity Scale (RDS) [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Departmant of Radiotherapy, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Taiwan	80756
2	Department of Radiation Oncology, China Medical University Hospital	Taichung	Taiwan
3	Department of Oncology, Taipei Verterans General Hospital	Taipei	Taiwan	11217

Sponsors and Collaborators

Joben Bio-Medical Co., Ltd.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Efficient Pharma Management Corp.

Investigators

Principal Investigator: Chih-Jen Huang, MD-PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
Principal Investigator: Cheng-Ying Shiau, MD, Taipei Verterans General Hospital
Principal Investigator: Chin-Nan Chu, MD, China Medical University Hospital