CompletedNCT02468141Updated Jul 21, 2017

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

An interventional study of SJDBT and Placebo in Cancer-related Problem/Condition, sponsored by Kyunghee University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by Kyunghee University Medical Center · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 20 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Cancer-related Problem/Condition

Browse trials for

Anorexia 411

In context

Anorexia

411 studies on the registry are indexed under Anorexia; 67 are open to participants now.

This study's enrollment of 32 is below the median of 41 across 287 interventional studies indexed under Anorexia.

Browse Anorexia studies →

Lead sponsor

Kyunghee University Medical Center is the lead sponsor of 62 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 32 participants (actual)

Study arms

Experimental
SJDBT group
Herbal medicine
Drug: SJDBT
Placebo comparator
Placebo
Placebo control
Drug: Placebo

Interventions

DrugSJDBT
Sipjeondaebo-tang
Also known as: Sipjeondaebotang
DrugPlacebo
Placebo
Also known as: Placebo control

What researchers measure

Primary outcomes

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

Secondary outcomes

FAACT scale
Time frame: 4 weeks

Study locations

1 site

Dunsan Korean Medicine Hospital
Daejeon, 302-869, Korea, Republic of

References and documents

Publications

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. doi: 10.1155/2018/6162106. PubMed 29441116 ↗
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. PubMed 27173813 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02468141
Lead sponsor: Kyunghee University Medical Center
Responsible party: Seong-Gyu Ko (Professor, Kyunghee University Medical Center) — Principal investigator
First posted: Jun 10, 2015
Start date: Jul 2015
Primary completion: Jun 2016
Completion: Sep 2016
Last update: Jul 21, 2017

Study contacts

Chunhoo Cheon, Master

study director · Institute of Safety and Efficiency Evaluation for Korean Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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