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NCT02858856 Clinical Trial

Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients

Breast Carcinoma Clinical Trial

Official title:
Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02858856
Other study ID # ISEE_2016_SJDBT
Secondary ID
Status Recruiting
Phase N/A
First received July 30, 2016
Last updated September 14, 2017
Start date March 20, 2017
Est. completion date June 2018

Study information
Verified date September 2017
Source Kyunghee University Medical Center
Contact Chunhoo Cheon
Phone 8229619278
Email khuksg@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date June 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- men and women aged over 18 years

- patients who have histologically or cytologically confirmed breast tumor

- patients who applicable AC(doxorubicin + cyclophosphamide)

- ECOG score 0 to 2

Exclusion Criteria:

- patient impossible to orally intake

- patient with dementia, delirium and depression

- patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis

- severe liver disability (3-fold the normal high range value for ALT, AST)

- patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,

- severe systemic disease

- use of other investigational products within the past 30 days

- hypersensitivity to investigational product

- others who are judged not to be appropriate to study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.

Locations
Country Name City State
Korea, Republic of International St. Mary's Hospital Incheon

Sponsors (2)
Lead Sponsor Collaborator
Kyunghee University Medical Center Catholic Kwandong University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brief Fatigue Inventory change 0-5 week
Primary Brief Fatigue Inventory change 6-11 week
Secondary EORTC-QLQ-C30 change 0-5 week, 6-11 week
Secondary EORTC-QLQ-BR23 change 0-5 week, 6-11 week
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