| 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 |
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Se-Heon Kim;Min Sik Kim;Young Mo Kim;Hyun Su Kim;Soon Yuhl Nam;Young Soo Rho;Young Hak Park;Chung Hwan Baek;Jung Pyo Bong;Kang Dae Lee;Yong Seop Lee;Kwang Yoon Jung;Sung Min Chung;Phil Sang Chung;Young Hoon Joo;Hyung Ro Chu;Eun Chang Choi;Kyung Tae;Ki |
| 방사선 치료 중인 두경부 종양 환자를 대상으로 메게이스 내복 현탁액 경구투여 후 유효성 및 안전성에 관한 다기관, 공개, 관측연구 |
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김세헌;김민식;김영모;김현수;남순열;노영수;박영학;백정환;봉정표;이강대;이용섭;정광윤;정성민;정필상;주영훈;주형로;최은창;태경;홍기환 |
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| Abstract |
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. |
| Key Words:
Megestrol acetate, Head and neck cancer, Radiotherapy, Weight loss, Anorexia |
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