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

Primary Purpose

Breast Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sipjeondaebo-tang
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • International St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A group

B group

Arm Description

Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks

Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks

Outcomes

Primary Outcome Measures

Brief Fatigue Inventory change
Brief Fatigue Inventory change

Secondary Outcome Measures

EORTC-QLQ-C30 change
EORTC-QLQ-BR23 change

Full Information

First Posted
July 30, 2016
Last Updated
September 14, 2017
Sponsor
Kyunghee University Medical Center
Collaborators
Catholic Kwandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02858856
Brief Title
Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Catholic Kwandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A group
Arm Type
Experimental
Arm Description
Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks
Arm Title
B group
Arm Type
Experimental
Arm Description
Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks
Intervention Type
Drug
Intervention Name(s)
Sipjeondaebo-tang
Other Intervention Name(s)
Deciten granule
Intervention Description
Herbal medicine which is a compound of 10 herbs.
Primary Outcome Measure Information:
Title
Brief Fatigue Inventory change
Time Frame
0-5 week
Title
Brief Fatigue Inventory change
Time Frame
6-11 week
Secondary Outcome Measure Information:
Title
EORTC-QLQ-C30 change
Time Frame
0-5 week, 6-11 week
Title
EORTC-QLQ-BR23 change
Time Frame
0-5 week, 6-11 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunhoo Cheon
Phone
8229619278
Email
khuksg@gmail.com
Facility Information:
Facility Name
International St. Mary's Hospital
City
Incheon
ZIP/Postal Code
22711
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHUNHOO CHEON, M.D.(DKM)
Phone
82-2-961-9278
Email
hreedom35@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29982213
Citation
Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.
Results Reference
derived

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

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