Abstract：
BACKGROUND: Capecitabine has been widely prescribed to treat various cancers. The hand foot syndrome (HFS) is the most troublesome adverse effect. Urea cream has been pre-emptively co-prescribed, even though its efficacy is doubtful. Aloe vera gel with urea cream might potentiate each other. This trial was intended to prove the efficacy of this combination.
METHODS: The investigators conducted a randomized single-blinded phase II study. The participants were randomized 1:1 to receive the combination of aloe vera gel and 10% urea cream (n = 30), the experimental A+U arm and 10% urea cream alone (n = 31), the U arm. The sample size was calculated to have 90% power to show the significant 20% reduction in the incidence of HFS grade 2-3 of the combination therapy with alpha level = 0.05. Both the CTCAE criteria version 5 and the dermatology life quality index (DLQI) were assessed to determine the severity of HFS and quality of life, respectively.
RESULTS: Most of the participants had rectal cancer (A+U: 43.3%; U: 41.9%). In the A+U group, 86.7% had grade 0-1 HFS and 13.3% had grade 2-3 HFS. In the U group, 64.5% had grade 0-1 HFS and 35.5% had grade 2-3 HFS (Mann-Whitney U test, p = 0.045). Grade 2-3 HFS was significantly lower in the combination group.
CONCLUSIONS: Combination of aloe vera gel and 10% urea cream ameliorated the severity of HFS in participants taking capecitabine; however, no significant difference in DLQI between the groups was demonstrated.
METHODS: The investigators conducted a randomized single-blinded phase II study. The participants were randomized 1:1 to receive the combination of aloe vera gel and 10% urea cream (n = 30), the experimental A+U arm and 10% urea cream alone (n = 31), the U arm. The sample size was calculated to have 90% power to show the significant 20% reduction in the incidence of HFS grade 2-3 of the combination therapy with alpha level = 0.05. Both the CTCAE criteria version 5 and the dermatology life quality index (DLQI) were assessed to determine the severity of HFS and quality of life, respectively.
RESULTS: Most of the participants had rectal cancer (A+U: 43.3%; U: 41.9%). In the A+U group, 86.7% had grade 0-1 HFS and 13.3% had grade 2-3 HFS. In the U group, 64.5% had grade 0-1 HFS and 35.5% had grade 2-3 HFS (Mann-Whitney U test, p = 0.045). Grade 2-3 HFS was significantly lower in the combination group.
CONCLUSIONS: Combination of aloe vera gel and 10% urea cream ameliorated the severity of HFS in participants taking capecitabine; however, no significant difference in DLQI between the groups was demonstrated.
摘要：
背景：卡培他滨已被广泛用于治疗各种癌症。手足综合征（HFS）是最麻烦的不良反应。尿素乳膏已被预先处方，尽管它的功效令人怀疑。芦荟凝胶与尿素霜可能会相互增强。该试验旨在证明该组合的功效。
方法：研究人员进行了一项随机单盲II期研究。参与者被随机分为1：1，接受芦荟凝胶和10％尿素乳膏的组合（n=30），实验A+U臂和单独的10%尿素乳膏(n=31)，U臂。样本量经计算具有90%的功效,以显示α水平=0.05的联合治疗的2-3级HFS的发生率显著降低20%。CTCAE标准第5版和皮肤病生活质量指数（DLQI）均进行了评估，以确定HFS的严重程度和生活质量，分别。
结果：大多数参与者患有直肠癌（A+U：43.3％；U：41.9％）。在A+U组中,86.7%有0-1级HFS，13.3%有2-3级HFS。在U组,64.5%有0-1级HFS，35.5%有2-3级HFS(Mann-WhitneyU检验，p=0.045)。2-3级HFS在组合组中显著降低。
结论：芦荟凝胶和10％尿素乳膏的组合可改善服用卡培他滨的参与者的HFS严重程度；然而，两组间DLQI无显著差异.
方法：研究人员进行了一项随机单盲II期研究。参与者被随机分为1：1，接受芦荟凝胶和10％尿素乳膏的组合（n=30），实验A+U臂和单独的10%尿素乳膏(n=31)，U臂。样本量经计算具有90%的功效,以显示α水平=0.05的联合治疗的2-3级HFS的发生率显著降低20%。CTCAE标准第5版和皮肤病生活质量指数（DLQI）均进行了评估，以确定HFS的严重程度和生活质量，分别。
结果：大多数参与者患有直肠癌（A+U：43.3％；U：41.9％）。在A+U组中,86.7%有0-1级HFS，13.3%有2-3级HFS。在U组,64.5%有0-1级HFS，35.5%有2-3级HFS(Mann-WhitneyU检验，p=0.045)。2-3级HFS在组合组中显著降低。
结论：芦荟凝胶和10％尿素乳膏的组合可改善服用卡培他滨的参与者的HFS严重程度；然而，两组间DLQI无显著差异.
