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KMID : 0356820080240010057
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Korean Journal of Head & Neck Oncology
2008 Volume.24 No. 1 p.57 ~ p.63
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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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Kim Se-Heon
Kim Min-Sik
Kim Young-Mo
Kim Hyun-Su
Nam Soon-Yuhl
Rho Young-Soo
Park Young-Hak
Baek Chung-Hwan
Bong Jeong-Pyo
Lee Kang-Dae
Lee Yong-Seop
Jung Kwang-Yoon
Chung Sung-Min
Chung Phil-Sang
Joo Young-Hoon
Chu Hyung-Ro
Choi Eun-Chang
Tae Kyung
Hong Ki-Hwan
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Abstract
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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.
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KEYWORD
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Megestrol acetate, Head and neck cancer, Radiotherapy, Weight loss, Anorexia
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