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

Cancer-related Problem/Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468141
• Other study ID #: KCRD_SJDBT_2015
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: July 19, 2017
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2017
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Cancer-related Problem/Condition

Intervention

Drug:
• SJDBT
Sipjeondaebo-tang
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Dunsan Korean Medicine Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale	Function scores as measured by the likert scale	4 weeks
Secondary	FAACT scale		4 weeks