Abstract：
BACKGROUND: Hand Foot Syndrome (HFS) is a frequent adverse effect observed in patients undergoing capecitabine chemotherapy, often leading to treatment disruptions and dose adjustments. Elevated C-Reactive Protein (hs-CRP) levels have been associated with the development of HFS. This study aimed to assess the potential of unrefined Extra Virgin Olive Oil (EVOO) supplementation in mitigating HFS and hs-CRP elevation among individuals receiving capecitabine chemotherapy.
METHODS: Between November 2022 and May 2023, forty-five eligible participants were enrolled in this randomized trial. Patients with advanced colorectal or breast cancer were randomly allocated into three groups: an intervention group receiving unrefined EVOO supplementation (30 mL per day) alongside capecitabine, a placebo group receiving refined extra light olive oil (ELOO) supplementation (30 mL per day) alongside capecitabine, and a control group receiving capecitabine alone. The masking of both placebo and intervention groups was ensured through identical packaging and instructions, maintaining participant and physician blindness to the assigned treatments. Randomization, achieved via computer-generated sequences, ensured even distribution among the three groups.
RESULTS: HFS incidences were notably lower in the EVOO group (13.3%) compared to the placebo (66.7%) and control (80%) groups. Instances of Grade 2 or more severe HFS were observed in 20% of placebo and 40% of control group patients. No cases of severe HFS were reported in the EVOO group. Moreover, EVOO supplementation led to a significant reduction in hs-CRP levels when contrasted with the placebo and control groups. These findings suggest that EVOO may serve as a preventive measure against HFS and exhibit anti-inflammatory effects in patients undergoing capecitabine chemotherapy.
CONCLUSIONS: This study demonstrates the potential benefits of incorporating unrefined EVOO into the regimen of patients undergoing capecitabine chemotherapy. EVOO supplementation was associated with lower incidences of HFS and a reduction in hs-CRP levels, indicating its possible role in preventing HFS development and mitigating inflammation.
METHODS: Between November 2022 and May 2023, forty-five eligible participants were enrolled in this randomized trial. Patients with advanced colorectal or breast cancer were randomly allocated into three groups: an intervention group receiving unrefined EVOO supplementation (30 mL per day) alongside capecitabine, a placebo group receiving refined extra light olive oil (ELOO) supplementation (30 mL per day) alongside capecitabine, and a control group receiving capecitabine alone. The masking of both placebo and intervention groups was ensured through identical packaging and instructions, maintaining participant and physician blindness to the assigned treatments. Randomization, achieved via computer-generated sequences, ensured even distribution among the three groups.
RESULTS: HFS incidences were notably lower in the EVOO group (13.3%) compared to the placebo (66.7%) and control (80%) groups. Instances of Grade 2 or more severe HFS were observed in 20% of placebo and 40% of control group patients. No cases of severe HFS were reported in the EVOO group. Moreover, EVOO supplementation led to a significant reduction in hs-CRP levels when contrasted with the placebo and control groups. These findings suggest that EVOO may serve as a preventive measure against HFS and exhibit anti-inflammatory effects in patients undergoing capecitabine chemotherapy.
CONCLUSIONS: This study demonstrates the potential benefits of incorporating unrefined EVOO into the regimen of patients undergoing capecitabine chemotherapy. EVOO supplementation was associated with lower incidences of HFS and a reduction in hs-CRP levels, indicating its possible role in preventing HFS development and mitigating inflammation.
摘要：
背景：手足综合征（HFS）是在接受卡培他滨化疗的患者中观察到的常见不良反应，通常导致治疗中断和剂量调整。C反应蛋白（hs-CRP）水平升高与HFS的发展有关。这项研究旨在评估未精制的特级初榨橄榄油（EVOO）补充剂在减轻接受卡培他滨化疗的个体中HFS和hs-CRP升高的潜力。
方法：在2022年11月至2023年5月之间，有45名符合条件的参与者参加了这项随机试验。晚期结直肠癌或乳腺癌患者被随机分为三组：干预组接受未精制的EVOO补充剂（每天30mL）和卡培他滨，安慰剂组接受精制的轻质橄榄油（ELOO）补充剂（每天30mL）以及卡培他滨，对照组仅接受卡培他滨。通过相同的包装和说明确保安慰剂组和干预组的掩蔽，保持参与者和医生对指定治疗的盲目性。随机化,通过计算机生成的序列实现，确保三组之间的均匀分布。
结果：与安慰剂组（66.7％）和对照组（80％）相比，EVOO组（13.3％）的HFS发生率明显较低。在20%的安慰剂组和40%的对照组患者中观察到2级或更严重HFS的情况。EVOO组未报告严重HFS病例。此外，与安慰剂组和对照组相比，补充EVOO导致hs-CRP水平显着降低。这些发现表明，EVOO可以作为HFS的预防措施，并在接受卡培他滨化疗的患者中表现出抗炎作用。
结论：这项研究证明了在接受卡培他滨化疗的患者的治疗方案中加入未精制的EVOO的潜在益处。EVOO补充剂与较低的HFS发生率和hs-CRP水平降低相关，表明其在预防HFS发展和减轻炎症中的可能作用。
方法：在2022年11月至2023年5月之间，有45名符合条件的参与者参加了这项随机试验。晚期结直肠癌或乳腺癌患者被随机分为三组：干预组接受未精制的EVOO补充剂（每天30mL）和卡培他滨，安慰剂组接受精制的轻质橄榄油（ELOO）补充剂（每天30mL）以及卡培他滨，对照组仅接受卡培他滨。通过相同的包装和说明确保安慰剂组和干预组的掩蔽，保持参与者和医生对指定治疗的盲目性。随机化,通过计算机生成的序列实现，确保三组之间的均匀分布。
结果：与安慰剂组（66.7％）和对照组（80％）相比，EVOO组（13.3％）的HFS发生率明显较低。在20%的安慰剂组和40%的对照组患者中观察到2级或更严重HFS的情况。EVOO组未报告严重HFS病例。此外，与安慰剂组和对照组相比，补充EVOO导致hs-CRP水平显着降低。这些发现表明，EVOO可以作为HFS的预防措施，并在接受卡培他滨化疗的患者中表现出抗炎作用。
结论：这项研究证明了在接受卡培他滨化疗的患者的治疗方案中加入未精制的EVOO的潜在益处。EVOO补充剂与较低的HFS发生率和hs-CRP水平降低相关，表明其在预防HFS发展和减轻炎症中的可能作用。
