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

Not Applicable

Completed

• Conditions: Cancer-related Problem/Condition
• Interventions: Drug: SJDBT; Drug: Placebo

• Registration Number: NCT02468141
• Lead Sponsor: Kyunghee University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-06-07
• Study First Posted: 2015-06-10
• Study Start: 2015-07
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-19
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SJDBT group	SJDBT	Herbal medicine
Placebo	Placebo	Placebo control

Primary Outcome Measures

Name	Time	Method
The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale	4 weeks	Function scores as measured by the likert scale

Secondary Outcome Measures

Name	Time	Method
FAACT scale	4 weeks

Trial Locations

Locations (1)

Dunsan Korean Medicine Hospital; 🇰🇷 Daejeon, Korea, Republic of