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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468141
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Seong-Gyu Ko, 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.

Condition or disease Intervention/treatment Phase
Cancer-related Problem/Condition Drug: SJDBT Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients: A Randomized Double Blinded Placebo Controlled Pilot Study
Actual Study Start Date : July 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: SJDBT group
Herbal medicine
Drug: SJDBT
Sipjeondaebo-tang
Other Name: Sipjeondaebotang

Placebo Comparator: Placebo
Placebo control
Drug: Placebo
Placebo
Other Name: Placebo control




Primary Outcome Measures :
  1. The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale [ Time Frame: 4 weeks ]
    Function scores as measured by the likert scale


Secondary Outcome Measures :
  1. FAACT scale [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468141


Locations
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Korea, Republic of
Dunsan Korean Medicine Hospital
Daejeon, Korea, Republic of, 302-869
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
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Study Director: Chunhoo Cheon, Master Institute of Safety and Efficiency Evaluation for Korean Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seong-Gyu Ko, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02468141    
Other Study ID Numbers: KCRD_SJDBT_2015
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Anorexia
Signs and Symptoms, Digestive