Clinical trial NCT02468141: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale
timeFrame: 4 weeks
Secondary outcomes:
measure: FAACT scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Dunsan Korean Medicine Hospital
Study officials:
affiliation: Institute of Safety and Efficiency Evaluation for Korean Medicine
name: Chunhoo Cheon, Master
role: STUDY_DIRECTOR
References:
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.
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.