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

NCT02289365 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-06-15

No results posted yet for this study

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.

Conditions

  • Radiodermatitis

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    collaborator OTHER

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • Efficient Pharma Management Corp.

    collaborator INDUSTRY

  • Joben Bio-Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chih-Jen Huang, MD-PhD · Kaohsiung Medical University Chung-Ho Memorial Hospital

  • Cheng-Ying Shiau, MD · Taipei Verterans General Hospital

  • Chin-Nan Chu, MD · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02289365 on ClinicalTrials.gov