| Summary: | 碩士 === 高雄醫學大學 === 職業安全衛生研究所 === 102 === Background: Breast cancer is the most common cancer of women in Taiwan and the incidence is increasing in these decades. In addition to surgery, the patients with breast cancer often receive adjuvant treatment such as chemotherapy (CT), radiotherapy (RT) and hormone therapy (HT). Some side effects occurred during or after radiotherapy, including skin reaction, fatigue and pain resulting in decreasing quality of life. Preliminary studies showed that the adlay bran showed function on anti-inflammatory effects.
Objective: The aim of this study is to evaluate the efficacy of adlay bran to reduce radiation-induced side effects in patients with breast cancer during radiotherapy, and using quality of life questionnaire to measure these patients before and after radiotherapy.
Methods: This study was a randomized, placebo-controlled double-blind clinical trial. Analysis and comparison of 132 breast cancer patients treated with radiation therapy, in which 83 patients with breast cancer and treatment of adlay bran extract as the trial group; 49 patients with the same treatment protocol but taking placebo. The data were collected by the same interviewer, including: case characteristics, medical records and questionnaires for quality of life (EORTC QLQ-C30 and EORTC QLQ-BR23) before and after RT. Clinical grading of skin were rated by a dermatologist. Adopt descriptive statistics, Pair-t test, independent t test, chi-square test, and logistic regression analysis and generalized estimating equations (GEE) were used to analysis the data. P-value <0.05 was considered statistically significant.
Results: We found the QLQ-C30 scales before and after RT between the trial group and control group in the three items: fatigue (p < 0.01), dyspnea (p < 0.05) and diarrhea (p < 0.05) showed reduced and significant by GEE analysis. But the other scales improvement were not significant. The difference in all the QLQ-BR23 scales between before and after RT between groups were not statistically significant.
Severe skin reaction of the breast patients after RT were significant (p=0.023).By multiple logistic regression analysis, the variables of groups, age, T-stage, N-stage, the total dose received, chemotherapy and diabetes for severe skin reaction, the OR of trial group compared to control was 0.37 (95% CI= 0.17-0.81). The blood tests between two groups were not significant difference.
Conclusions: There was significant changes in symptoms scores of fatigue and diarrohea at RT conclusion from pre-RT. Our results indicate that adlay bran extract may have a potential to protect patients without increasing their risk of serious adverse effects. The adlay bran extract did not change blood biochemical reactions of the breast patients before and after RT.
KEYWORDS: Breast cancer, EORTC, Quality of Life, Radiotherapy
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