Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus; University of Turku, Department of Nursing, Finland.
Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus.
Eur J Oncol Nurs. 2021 Feb;50:101866. doi: 10.1016/j.ejon.2020.101866. Epub 2020 Nov 11.
Palmar-Plantar Erythrodysesthesia (PPE) is a dose-limiting adverse event that commonly occurs with capecitabine and Pegylated Liposomal Doxorubicin-PLD treatment. The study aimed to test the effectiveness of a Pyridoxine (B6) treatment protocol in the management of PPE in patients receiving treatment with capecitabine or pegylated liposomal doxorubicin.
This was a pilot randomized double-blind, placebo-controlled study. Patients receiving capecitabine or pegylated liposomal doxorubicin with PPE grade 1 or above were randomly allocated to receive pyridoxine or placebo. The PPE grade, Quality of Life-QoL, Pain and patients' activities of daily living were assessed.
Thirty patients were assigned in the Control and 24 in the Intervention group. No statistically significant difference was found in the PPE grade between baseline and week 6 in the 2 groups (p = 0.263). The control group exhibited worst PPE-associated QoL and higher PAIN levels between baseline and week 6. Respectively, the intervention group showed improved PPE-associated QoL and lower PAIN levels. At week 6, the ECOG status in the Intervention group was improved compared to the control (p = 0.018). Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
Topical pyridoxine was not shown to have an effect on the treatment of PPE. However, results demonstrated its effectiveness on health related QoL, QoL-associated with PPE and pain levels. Due to the high attrition rate further validation of these results in a larger population is warranted. CLINICALTRIALS.
NCT02625415.
手掌-足底红斑感觉异常（PPE）是一种常见的卡培他滨和聚乙二醇脂质体阿霉素-PLD 治疗的剂量限制不良事件。本研究旨在测试吡哆醇（B6）治疗方案在管理接受卡培他滨或聚乙二醇脂质体阿霉素治疗的患者 PPE 中的有效性。
这是一项试点随机双盲、安慰剂对照研究。接受卡培他滨或聚乙二醇脂质体阿霉素治疗且 PPE 等级为 1 级或更高的患者被随机分配接受吡哆醇或安慰剂。评估了 PPE 等级、生活质量（QoL）、疼痛和患者的日常生活活动。
30 名患者被分配到对照组，24 名患者被分配到干预组。两组基线和第 6 周时 PPE 等级无统计学差异（p=0.263）。对照组在基线和第 6 周时 PPE 相关 QoL 最差，疼痛水平最高。相比之下，干预组显示出改善的 PPE 相关 QoL 和较低的疼痛水平。第 6 周时，干预组的 ECOG 状态较对照组改善（p=0.018）。干预组患者的总体健康状况（p=0.012）、身体状况（p=0.003）、情绪状况（p=0.008）和社会功能状况（p<0.001）更好，疲劳程度（p=0.001）和疼痛程度（p=0.006）更低。
局部吡哆醇对治疗 PPE 没有效果。然而，结果表明它对健康相关的 QoL、与 PPE 相关的 QoL 和疼痛水平有效果。由于高脱落率，需要在更大的人群中进一步验证这些结果。临床试验。
GOV 标识符：NCT02625415。
