Ingersoll Gail L, Wasilewski Amy, Haller Michele, Pandya Kishan, Bennett John, He Hua, Hoffmire Claire, Berry Cynthia
University of Rochester Medical Center, New York, USA.
Oncol Nurs Forum. 2010 Mar;37(2):213-21. doi: 10.1188/10.ONF.213-221.
PURPOSE/OBJECTIVES: To determine the feasibility of administering a flavonoid-rich adjunctive treatment (Concord grape juice) for the management of chemotherapy-induced nausea and vomiting (CINV); to evaluate the usefulness of existing measures for assessing CINV frequency and severity, quality of life, control over life events, and psychological state; to identify any actual or potential adverse events associated with frequent grape juice intake; and to provide preliminary data concerning the effect of Concord grape juice on CINV, quality of life, perceived control over life events, and psychological state.
Double-blind, randomized clinical trial.
A cancer center in an academic health science center in the northeastern United States.
77 adult patients with cancer receiving moderately or highly emetogenic chemotherapy agents.
Participants drank 4 oz. of grape juice or placebo prior to meals for one week following each of four chemotherapy treatment cycles. They recorded frequency, duration, and distress of nausea, vomiting, and retching daily, beginning the evening of chemotherapy administration and continuing for seven days. Data were analyzed with generalized estimating equations methodology to model differences between groups over time.
Nausea and vomiting frequency, duration, and distress; quality of life; control over decision making; and psychological state.
Nausea and vomiting frequency, duration, and distress were lower for experimental group members, although a high attrition rate (50%) resulted in insufficient power to detect statistically significant differences over time. Greater levels of anxiety, depression, and hostility at baseline were related to nausea and vomiting, quality of life, and perceived control over decision making.
The effect of grape juice flavonoids on CINV should be investigated further with a larger sample to determine whether preliminary findings are supported. Alterations to the study protocol will be necessary to decrease attrition.
Flavonoid-rich fruits and vegetables may provide additional protection against CINV. If the compounds work, they would offer a low-cost, readily available adjunctive treatment for the management of CINV.
目的/目标:确定给予富含类黄酮的辅助治疗(康科德葡萄汁)来管理化疗引起的恶心和呕吐(CINV)的可行性;评估现有措施在评估CINV频率和严重程度、生活质量、对生活事件的掌控以及心理状态方面的有用性;识别与频繁饮用葡萄汁相关的任何实际或潜在不良事件;并提供关于康科德葡萄汁对CINV、生活质量、对生活事件的感知掌控以及心理状态影响的初步数据。
双盲、随机临床试验。
美国东北部一所学术健康科学中心的癌症中心。
77名接受中度或高度致吐性化疗药物的成年癌症患者。
参与者在四个化疗治疗周期中的每一个周期后的一周内,每餐饭前饮用4盎司葡萄汁或安慰剂。他们从化疗给药当晚开始,每天记录恶心、呕吐和干呕的频率、持续时间和痛苦程度,并持续七天。数据采用广义估计方程法进行分析,以模拟不同组随时间的差异。
恶心和呕吐的频率、持续时间和痛苦程度;生活质量;决策掌控;以及心理状态。
实验组成员的恶心和呕吐频率、持续时间和痛苦程度较低,尽管高失访率(50%)导致检测随时间变化的统计学显著差异的效能不足。基线时较高水平的焦虑、抑郁和敌意与恶心和呕吐、生活质量以及对决策的感知掌控有关。
应使用更大样本进一步研究葡萄汁类黄酮对CINV的影响,以确定初步研究结果是否得到支持。有必要对研究方案进行调整以减少失访。
富含类黄酮的水果和蔬菜可能为预防CINV提供额外保护。如果这些化合物有效,它们将为管理CINV提供一种低成本、易于获得的辅助治疗方法。