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

Not Applicable

• Conditions: Breast Carcinoma
• Interventions: Drug: Sipjeondaebo-tang

• Registration Number: NCT02858856
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-30
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-08
• Study Start: 2017-03-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-15
• Primary Completion: 2018-03
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A group	Sipjeondaebo-tang	Take Sipjeondaebo-tang on 0\~2 week, 3\~5 week of clinical trial period, total of 4 weeks
B group	Sipjeondaebo-tang	Take Sipjeondaebo-tang on 6\~8 week, 9\~11 week of clinical trial period, total of 4 weeks

Primary Outcome Measures

Name	Time	Method
Brief Fatigue Inventory change	6-11 week

Secondary Outcome Measures

Name	Time	Method
EORTC-QLQ-BR23 change	0-5 week, 6-11 week
EORTC-QLQ-C30 change	0-5 week, 6-11 week

Trial Locations

Locations (1)

International St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of