Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients

NCT01359501 | Unknown Phase 2 DMC

• 2 other identifiers: DMR99-IRB-259CCMP99-RD-050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy in breast cancer patients.

Conditions

Leucopenia; Breast Cancer

Keywords

patients receiving chemotherapy

Outcome Measures

Primary Outcomes (1)

• WBC Count

  All the patients will be stratified according to her chemotherapy protocol : "FEC\*6", "FEC\*4+Taxotere\*4", and "FEC\*3+Taxotere\*3". The WBC will be checked before receiving each cycle of chemotherapy and at the follow up 3 weeks after the completion of chemotherapy. If the participator receives the protocol "FEC\*6", her WBC will be checked every 3 weeks for 7 times. It will takes 21 weeks to get the values of WBC at 7 different time point. And it will takes 31 weeks and 24 weeks for participators receive the protocol "FEC\*4+Taxotere\*4" and "FEC\*3+Taxotere\*3", respectively.

  21-31 weeks, which depands on the patients' chemotherapy protocol.

Secondary Outcomes (1)

• Score of EORTC QLQ-C30

  21-31 weeks, which depands on the patients' chemotherapy protocol.

Study Arms (2)

Chinese medical treatment

EXPERIMENTAL

Drug: Chinese medical treatment-LCH1

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Chinese medical treatment-LCH1 DRUG

Start to take the powder of Chinese herb-LCH1 3g\*BID just after the 1st chemotherapy, and Stop 2-3 weeks after the final cycle of chemotherapy.

Chinese medical treatment

Placebo DRUG

Start to take the powder of Placebo 3g\*BID just after the 1st chemotherapy, and stop 2-3 weeks after the final chemotherapy.

Placebo

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed breast cancer patient (age ≧18, Stage I, II, IIIa)
• Receive chemotherapy after operation

You may not qualify if:

• Before receiving operation and chemotherapy, the patient already have other chronic diseases.
• Already have hematological malignancy and other lethal disease.
• Pregnant.
• Have severe psychological diseases.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator

Study Sites (3)

Devision of Breast Surgery, China Medical University Hospital

Taichung, Taiwan, 40421, Taiwan

ENROLLING BY INVITATION

Devision of Breast Surgery, China Medical University Hospital

Taichung, Taiwan, 404, Taiwan

RECRUITING

Division of General surgery, Tri-Service General Hospital

Taipei, Taiwan, 114, Taiwan

ENROLLING BY INVITATION

MeSH Terms

Conditions

Leukopenia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hwei-Chung Wang, MD.

  Devision of Breast Surgery, China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Yi-Chang Su, MD., PhD.

  School of Chinese Medicine, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Jui-Shan, MD., PhD.

CONTACT

886-4-22053366; taco423@ms26.hinet.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2011
• First Posted: May 24, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 23, 2012

Record last verified: 2012-10

Locations

TW (3)