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

NCT02289365 | Unknown Phase 2 DMC

• 2 other identifiers: JBM-001IND 117691
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Radiodermatitis

Keywords

Radiodermatitis; Breast cancer; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Radiation Dermatitis Severity Scale (RDS)

  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.

  baseline to 92 days

Secondary Outcomes (8)

• Presence of Moist Desquamation

  baseline to 92 days

• Redness Scale

  baseline to 92 days

• Worst Pain Related to Radiodermatitis at the site

  baseline to 92 days

• Improve Quality of Life

  92 days

• Vital sign

  baseline to 92 days

Study Arms (3)

Group I

PLACEBO COMPARATOR

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

Group II

EXPERIMENTAL

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

Group III

EXPERIMENTAL

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

Interventions

2000 mg of JBM-TC4 per day DRUG

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 II

3000 mg of JBM-TC4 per day DRUG

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.

Group III

3000 mg of PEG-400 per day DRUG

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 I

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Departmant of Radiotherapy, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 80756, Taiwan

Location

Department of Oncology, Taipei Verterans General Hospital

Taipei, Taiwan, 11217, Taiwan

Location

Department of Radiation Oncology, China Medical University Hospital

Taichung, Taiwan

Location

Related Publications (11)

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MeSH Terms

Conditions

Radiodermatitis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

TW (3)