Skip to main content
OpenTrials
Completed

NCT Number: NCT02468141

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dunsan Korean Medicine Hospital

Daejeon, 302-869, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SJDBT

Drug

Sipjeondaebo-tang

Other names: Sipjeondaebotang

Placebo

Drug

Placebo

Other names: Placebo control

Primary outcomes

  1. The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale

    Time frame: 4 weeks

    Function scores as measured by the likert scale

Secondary outcomes

  1. FAACT scale

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2015
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.