Back to resultsEffect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
Primary Purpose
Cancer-related Problem/Condition
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SJDBT
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer-related Problem/Condition
Eligibility Criteria
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
Sites / Locations
- Dunsan Korean Medicine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SJDBT group
Placebo
Arm Description
Herbal medicine
Placebo control
Outcomes
Primary Outcome Measures
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
Function scores as measured by the likert scale
Secondary Outcome Measures
FAACT scale
Full Information
NCT ID
NCT02468141
First Posted
May 27, 2015
Last Updated
July 19, 2017
Sponsor
Kyunghee University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02468141
Brief Title
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
Official Title
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Problem/Condition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SJDBT group
Arm Type
Experimental
Arm Description
Herbal medicine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo control
Intervention Type
Drug
Intervention Name(s)
SJDBT
Other Intervention Name(s)
Sipjeondaebotang
Intervention Description
Sipjeondaebo-tang
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo control
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
Description
Function scores as measured by the likert scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
FAACT scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunhoo Cheon, Master
Organizational Affiliation
Institute of Safety and Efficiency Evaluation for Korean Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Dunsan Korean Medicine Hospital
City
Daejeon
ZIP/Postal Code
302-869
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29441116
Citation
Cheon C, Yoo JE, Yoo HS, Cho CK, Kang S, Kim M, Jang BH, Shin YC, Ko SG. Efficacy and Safety of Sipjeondaebo-Tang for Anorexia in Patients with Cancer: A Pilot, Randomized, Double-Blind, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2017;2017:8780325. doi: 10.1155/2017/8780325. Epub 2017 Dec 26. Erratum In: Evid Based Complement Alternat Med. 2018 Jul 30;2018:6162106.
Results Reference
derived
PubMed Identifier
27173813
Citation
Cheon C, Park S, Park YL, Huang CW, Ko Y, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with cancer with anorexia: a protocol for a pilot, randomised, controlled trial. BMJ Open. 2016 May 12;6(5):e011212. doi: 10.1136/bmjopen-2016-011212.
Results Reference
derived
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Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients
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