방사선 치료 중인 두경부 종양 환자를 대상으로 메게이스 내복 현탁액 경구투여 후 유효성 및 안전성에 관한 다기관, 공개, 관측연구

Multicenter, Open-Labeled, Observational Clinical Trial to Investigate the Efficacy and Safety of Oral Administration of Megace Suspension in Patients with Head and Neck Cancer During Radiotherapy

  • 김세헌 (연세대학교 의과대학 이비인후과학교실) ;
  • 김민식 (가톨릭대학교 의과대학 이비인후-두경부외과학교실) ;
  • 김영모 (인하대학교 의과대학 이비인후-두경부외과학교실) ;
  • 김현수 (연세대학교 의과대학 이비인후과학교실) ;
  • 남순열 (울산대학교 의과대학 서울아산병원 이비인후과학교실) ;
  • 노영수 (한림대학교 의과대학 이비인후-두경부외과학교실) ;
  • 박영학 (가톨릭대학교 의과대학 이비인후-두경부외과학교실) ;
  • 백정환 (성균관대학교 의과대학 삼성서울병원 이비인후-두경부외과학교실) ;
  • 봉정표 (연세대학교 원주의과대학 이비인후-두경부외과학교실) ;
  • 이강대 (고신대학교 의과대학 복음병원 이비인후과학교실) ;
  • 이용섭 (한양대학교 의과대학 이비인후-두경부외과학교실) ;
  • 정광윤 (고려대학교 의과대학 이비인후-두경부외과학교실) ;
  • 정성민 (이화여자대학교 의과대학 이비인후과학교실) ;
  • 정필상 (단국대학교 의과대학 이비인후-두경부외과학교실) ;
  • 주영훈 (가톨릭대학교 의과대학 이비인후-두경부외과학교실) ;
  • 주형로 (한림대학교 의과대학 이비인후-두경부외과학교실) ;
  • 최은창 (연세대학교 의과대학 이비인후과학교실) ;
  • 태경 (한양대학교 의과대학 이비인후-두경부외과학교실) ;
  • 홍기환 (전북대학교 의과대학 이비인후-두경부외과학교실)
  • Kim, Se-Heon (Department of Otorhinolaryngology, Yonsei University College of Medicine) ;
  • Kim, Min-Sik (Department of Otolaryngology-Head and Neck Surgery, The Catholic University of Korea College of Medicine) ;
  • Kim, Young-Mo (Department of Otorhinolaryngology-Head & Neck Surgery, Inha University College of Medicine) ;
  • Kim, Hyun-Su (Department of Otorhinolaryngology, Yonsei University College of Medicine) ;
  • Nam, Soon-Yuhl (Department of Otolaryngology, Asan Medical Center, College of Medicine, University of Ulsan) ;
  • Rho, Young-Soo (Department of Otorhinolaryngology-Head and Neck Surgery, Hallym University College of Medicine) ;
  • Park, Young-Hak (Department of Otolaryngology-Head and Neck Surgery, The Catholic University of Korea College of Medicine) ;
  • Baek, Chung-Hwan (Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Bong, Jung-Pyo (Department of Otolaryngology-Head and Neck Surgery, Yonsei University, Wonju College of Medicine) ;
  • Lee, Kang-Dae (Department of Otolaryngology, College of Medicine, Kosin University, Gospel Hospital) ;
  • Lee, Yong-Seop (Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University) ;
  • Jung, Kwang-Yoon (Department of Otorhinolayngology-Head and Neck Surgery, Korea University College of Medicine) ;
  • Chung, Sung-Min (Department of Otolaryngology, School of Medicine, Ewha Womans University) ;
  • Chung, Pil-Sang (Department of Otolaryngology-Head and Neck Surgery, Dankook Univerity College of Medicine) ;
  • Joo, Young-Hoon (Department of Otolaryngology-Head and Neck Surfery, The Catholic University of Korea College of Medicine) ;
  • Chu, Hyung-Ro (Department of Otorhinolaryngology-Head and Neck Surgery, Hallym University College of Medicine) ;
  • Choi, Eun-Chang (Department of Otorhinolarynology, Yonsei University College of Medicine) ;
  • Tae, Kyung (Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University) ;
  • Hong, Ki-Hwan (Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Chonbuk National University)
  • 발행 : 2008.05.31

초록

Background and Purpose:Nausea, vomiting and weight loss are common problems that are encountered in the course of cancer patient treatment who are receiving radiotherapy. In this study, we are aiming to analyze the effect of megestrol acetate on quality of life of head and neck cancer patients receiving radiotherapy, resulting from improvement of weight loss, appetite and nutritional status via multicenter, open-labeled, observational clinical trial. Material and Methods:A total of 270 patients from 10 medical institutes who are receiving radiotherapy or who have completed radiotherapy within 3 months, between February 2007 and February 2008, were selected as candidates for the study. Megestrol acetate suspension(megace) was given to the subjectives once a week for 4 weeks with the amount of 20ml(megestrol 800mg). Measurement of weight and questionnaire surveys were carried out three times: at the start of the study, 4 weeks after the start of the medication, and 4 weeks after the end of the medication, respectively. Results:The group who has received megace had a total number of 199, and control group was 70. The group who have received megace showed mean weight loss of 1kg in 8 weeks, compared with the weight loss of 5.5kg in control group, which showed that the medication was effective in reducing the amount of weight loss(P=0.027). The group who received megace had a tendency to report a reduced rate of decrease in the score of appetite, nausea and vomiting, and QOL score, but it did not have statistical significance(P>0.05). Conclusion:Megestrol acetate have reduced the degree of weight loss significantly, and it has a tendency to reduce the rate of decrease in appetite, aggravation of nausea and vomiting, and quality of life.

키워드

참고문헌

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