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

NCT02468141 | Completed DMC

• 1 other identifier: KCRD_SJDBT_2015
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Problem/Condition

Outcome Measures

Primary Outcomes (1)

• The Functional Assessment of Anorexia/Cachexia Therapy - Anorexia Cachexia Subscale

  Function scores as measured by the likert scale

  4 weeks

Secondary Outcomes (1)

• FAACT scale

  4 weeks

Study Arms (2)

SJDBT group

EXPERIMENTAL

Herbal medicine

Drug: SJDBT

Placebo

PLACEBO COMPARATOR

Placebo control

Drug: Placebo

Interventions

SJDBT DRUG

Sipjeondaebo-tang

Also known as: Sipjeondaebotang

SJDBT group

Placebo DRUG

Placebo

Also known as: Placebo control

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Dunsan Korean Medicine Hospital

Daejeon, 302-869, South Korea

Location

Related Publications (2)

• 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.

  PMID: 29441116 DERIVED

• 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.

  PMID: 27173813 DERIVED

Study Officials

• Chunhoo Cheon, Master

  Institute of Safety and Efficiency Evaluation for Korean Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 10, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

KR (1)