Herbal Formula Science (대한한의학방제학회지)

The Korean Medicine Society for the Herbal Formula Study (대한한의학방제학회)
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Effect of Salvia plebeia Extract on Patients with Solid Cancer: A Preliminary Clinical Trial Protocol

배암차즈기의 투여가 고형암환자에 미치는 영향을 평가하기 위한 선행적 인체적용시험

  • Boram, Lee (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Sookjin, Pyo (East West Cancer Center, Daejeon Korean Medicine Hospital) ;
  • Ae-Ran, Kim (Clinical Research Coordinating Team, Korea Institute of Oriental Medicine) ;
  • Eunbin, Kwag (East West Cancer Center, Daejeon Korean Medicine Hospital) ;
  • Jang-Gi, Choi (KM Application Center, Korea Institute of Oriental Medicine) ;
  • Hwaseung, Yoo (East West Cancer Center, Seoul Korean Medicine Hospital, Daejeon ) ;
  • Hwan-Suck, Chung (KM Application Center, Korea Institute of Oriental Medicine) ;
  • Jongkwan, Jo (East West Cancer Center, Daejeon Korean Medicine Hospital)
  • 이보람 (한국한의학연구원 한의과학연구부) ;
  • 표숙진 (대전대학교 대전한방병원 동서암센터) ;
  • 김애란 (한국한의학연구원 임상연구협력팀) ;
  • 곽은빈 (대전대학교 대전한방병원 동서암센터) ;
  • 최장기 (한국한의학연구원 한의기술응용센터) ;
  • 유화승 (대전대학교 서울한방병원 동서암센터) ;
  • 정환석 (한국한의학연구원 한의기술응용센터) ;
  • 조종관 (대전대학교 대전한방병원 동서암센터)
  • Received : 2022.09.06
  • Accepted : 2022.11.02
  • Published : 2022.11.30
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Abstract

Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

Keywords

Acknowledgement

This work is supported by the Korea Institute of Oriental Medicine (grant no. KSN2022230). The funding source will have no input regarding the interpretation or publication of the study's results.

References

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