Orally Administrated JBM-TC4 Prevents Acute Radiodermatitis in Breast Cancer Patients
NCT ID: NCT02289365
Last Updated: 2016-06-15
Study Results
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Basic Information
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UNKNOWN
PHASE2
120 participants
INTERVENTIONAL
2014-11-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group I
Totally 3000 mg of PEG-400 per day. 3 capsules of 500 mg PEG-400 per time, twice a day.
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.
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.
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.
Group III
Totally 3000 mg of JBM-TC4 per day. 3 capsules of 500 mg JBM-TC4 per time, twice a day.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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Kaohsiung Medical University Chung-Ho Memorial Hospital
OTHER
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Efficient Pharma Management Corp.
INDUSTRY
Joben Bio-Medical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chih-Jen Huang, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Kaohsiung Medical University Chung-Ho Memorial Hospital
Cheng-Ying Shiau, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Verterans General Hospital
Chin-Nan Chu, MD
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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Departmant of Radiotherapy, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
Department of Oncology, Taipei Verterans General Hospital
Taipei, Taiwan, Taiwan
Department of Radiation Oncology, China Medical University Hospital
Taichung, , Taiwan
Countries
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References
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Chen HJ, Lo YC, Chiang W. Inhibitory effects of adlay bran (Coix lachryma-jobi L. var. ma-yuen Stapf) on chemical mediator release and cytokine production in rat basophilic leukemia cells. J Ethnopharmacol. 2012 May 7;141(1):119-27. doi: 10.1016/j.jep.2012.02.009. Epub 2012 Feb 14.
Chung CP, Hsu CY, Lin JH, Kuo YH, Chiang W, Lin YL. Antiproliferative lactams and spiroenone from adlay bran in human breast cancer cell lines. J Agric Food Chem. 2011 Feb 23;59(4):1185-94. doi: 10.1021/jf104088x. Epub 2011 Feb 1.
Chung CP, Hsia SM, Lee MY, Chen HJ, Cheng F, Chan LC, Kuo YH, Lin YL, Chiang W. Gastroprotective activities of adlay (Coix lachryma-jobi L. var. ma-yuen Stapf) on the growth of the stomach cancer AGS cell line and indomethacin-induced gastric ulcers. J Agric Food Chem. 2011 Jun 8;59(11):6025-33. doi: 10.1021/jf2009556. Epub 2011 May 5.
Hung WC, Chang HC. Methanolic extract of adlay seed suppresses COX-2 expression of human lung cancer cells via inhibition of gene transcription. J Agric Food Chem. 2003 Dec 3;51(25):7333-7. doi: 10.1021/jf0340512.
Kuo CC, Shih MC, Kuo YH, Chiang W. Antagonism of free-radical-induced damage of adlay seed and its antiproliferative effect in human histolytic lymphoma U937 monocytic cells. J Agric Food Chem. 2001 Mar;49(3):1564-70. doi: 10.1021/jf001215v.
Kuo CC, Chen HH, Chiang W. Adlay ( yi yi; "soft-shelled job's tears"; the seeds of Coix lachryma-jobi L. var. ma-yuen Stapf) is a Potential Cancer Chemopreventive Agent toward Multistage Carcinogenesis Processes. J Tradit Complement Med. 2012 Oct;2(4):267-75. doi: 10.1016/s2225-4110(16)30112-2.
Lee MY, Lin HY, Cheng F, Chiang W, Kuo YH. Isolation and characterization of new lactam compounds that inhibit lung and colon cancer cells from adlay (Coix lachryma-jobi L. var. ma-yuen Stapf) bran. Food Chem Toxicol. 2008 Jun;46(6):1933-9. doi: 10.1016/j.fct.2008.01.033. Epub 2008 Feb 12.
Li SC, Chen CM, Lin SH, Chiang W, Shih CK. Effects of adlay bran and its ethanolic extract and residue on preneoplastic lesions of the colon in rats. J Sci Food Agric. 2011 Feb;91(3):547-52. doi: 10.1002/jsfa.4219. Epub 2010 Nov 19.
Yao HT, Lin JH, Chiang MT, Chiang W, Luo MN, Lii CK. Suppressive effect of the ethanolic extract of adlay bran on cytochrome P-450 enzymes in rat liver and lungs. J Agric Food Chem. 2011 Apr 27;59(8):4306-14. doi: 10.1021/jf200117m. Epub 2011 Mar 18.
Zhan YP, Huang XE, Cao J, Lu YY, Wu XY, Liu J, Xu X, Xiang J, Ye LH. Clinical safety and efficacy of Kanglaite(R) (Coix Seed Oil) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev. 2012;13(10):5319-21. doi: 10.7314/apjcp.2012.13.10.5319.
Other Identifiers
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IND 117691
Identifier Type: OTHER
Identifier Source: secondary_id
JBM-001
Identifier Type: -
Identifier Source: org_study_id
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