Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients

July 19, 2017 updated by: Seong-Gyu Ko, Kyunghee University Medical Center

Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study

To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

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

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women ages 20 to 80 years
  • Individuals who are suffering from cancer-associated anorexia
  • Patients within 1 month after completion of chemotherapy
  • No plan for additional chemotherapy or radiotherapy
  • Anorexia visual analogue scale (VAS) ≥ 40/100mm
  • Qi deficiency scale ≥ 30 or Blood deficiency scale ≥ 30
  • Neutrophil ≥ 1,500/㎕, platelet ≥ 100,000/㎕
  • Total bilirubin lower than upper limit of normal (1.2 mg/㎗)
  • ALT, AST lower than 2-fold the upper limit of normal
  • Creatinine lower than 1.5 fold the upper limit of normal(1.09 mg/㎗)
  • Written informed consent for participation in the trial

Exclusion Criteria:

  • Patient impossible to oral intake
  • Patient 5 years after cancer diagnosis
  • ECOG performance status score > 3
  • Patient with dementia, delirium, depression
  • Patient who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of screening
  • Patient with diseases which can influence on appetite (such as hypoadrenalism, etc)
  • Patient who are taking appetizers (such as megestrol acetate, corticosteroids, thalidomide)
  • Women who has possibility of a pregnancy
  • 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo control
Drug: Placebo
Placebo
Other Names:
  • Placebo control
Experimental: SJDBT group
Herbal medicine
Drug: SJDBT
Sipjeondaebo-tang
Other Names:
  • Sipjeondaebotang

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
Time Frame: 4 weeks
Function scores as measured by the likert scale
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
FAACT scale
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Investigators

  • Study Director: Chunhoo Cheon, Master, Institute of Safety and Efficiency Evaluation for Korean Medicine

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)

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

June 7, 2015

First Posted (Estimate)

June 10, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCRD_SJDBT_2015

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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