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

September 14, 2017 updated by: Seong-Gyu Ko, Kyunghee University Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 22711
        • Recruiting
        • International St. Mary's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group
Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks
Drug: Sipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.
Other Names:
  • Deciten granule
Experimental: B group
Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks
Drug: Sipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.
Other Names:
  • Deciten granule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Fatigue Inventory change
Time Frame: 0-5 week
0-5 week
Brief Fatigue Inventory change
Time Frame: 6-11 week
6-11 week

Secondary Outcome Measures

Outcome Measure
Time Frame
EORTC-QLQ-C30 change
Time Frame: 0-5 week, 6-11 week
0-5 week, 6-11 week
EORTC-QLQ-BR23 change
Time Frame: 0-5 week, 6-11 week
0-5 week, 6-11 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Collaborators

Catholic Kwandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 30, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISEE_2016_SJDBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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