Table_1_Fasting mimicking diet during neo-adjuvant chemotherapy in breast cancer patients: a randomized controlled trial study.DOCX

ObjectivePreclinical evidences suggests that while fasting can reduce the side effects and toxicity of chemotherapy, it can make cancer cells more susceptible to chemotherapy. This study aimed to examine the effects of fasting mimicking diet (FMD) during neo-adjuvant chemotherapy in breast cancer (BC) patients.
MethodsForty-four newly diagnosed human epidermal growth factor receptor 2-negative (HER2-negative) patients with BC were randomized equally into two groups (22 each), to receive either a fasting mimicking diet (FMD) or their regular diet for 3 days prior to and during neoadjuvant chemotherapy. This FMD was repeated every 3 weeks for 8 cycles. Efficacy, toxicity, hematologic, metabolic, and inflammatory parameters were measured and compared.
ResultsThe occurrence of grade III vomiting and neutropenia in the control group was significantly higher than the FMD group (P = <0.001 and p = 0.04 respectively). Erythrocytes (p = 0.01) and neutrophils (p = 0.002) counts were significantly higher in FMD group compared to control group after cycle 8. There was a significant increase in median glucose and median insulin levels (p = 0.01 and p = 0.005, respectively) in the control group between baseline and after cycle 8. While, the median Insulin-like growth factor-1 (IGF1) (p = 0.006) and hs-CRP (p = 0.02) levels were significantly decreased in the FMD group. At the end of study (after cycle 8), the median glucose level was significantly higher in control group (p = 0.008), while the median hs-CRP level was significantly lower in FMD group (p = 0.01). The Miller and Payne pathological response 4/5 (90–100% tumor cell loss) and the radiologically complete or partial response, as measured by MRI or ultrasound before surgery occurred more frequently in FMD group compared to the controls (p = 0.01).
ConclusionFasting mimicking diet was well tolerated during chemotherapy and reduced toxicity of chemotherapy and also, had beneficial effects of some metabolic parameters.
Clinical Trial Registrationhttps://irct.behdasht.gov.ir/user/trial/61386/view.

研究目的：临床前研究证据表明，禁食可减轻化疗的不良反应与毒性，同时能增强癌细胞对化疗的敏感性。本研究旨在探讨乳腺癌（breast cancer, BC）患者新辅助化疗期间应用禁食模拟饮食（fasting mimicking diet, FMD）的效果。研究方法：将44例新确诊的人表皮生长因子受体2阴性（human epidermal growth factor receptor 2-negative, HER2阴性）乳腺癌患者按1:1随机分为两组（各22例），分别在新辅助化疗前3天及化疗期间接受禁食模拟饮食（FMD）或常规饮食，该饮食方案每3周重复1次，共8个周期。检测并比较两组的疗效、毒性反应、血液学指标、代谢指标及炎症指标。研究结果：对照组Ⅲ级呕吐及中性粒细胞减少的发生率显著高于FMD组（分别为P<0.001及P=0.04）。第8个周期结束后，FMD组的红细胞计数（P=0.01）及中性粒细胞计数（P=0.002）均显著高于对照组。对照组基线至第8个周期后，中位血糖及中位胰岛素水平显著升高（分别为P=0.01及P=0.005）；而FMD组的中位胰岛素样生长因子-1（Insulin-like growth factor-1, IGF1）及超敏C反应蛋白（high-sensitivity C-reactive protein, hs-CRP）水平显著降低（分别为P=0.006及P=0.02）。研究结束时（第8个周期后），对照组中位血糖水平显著升高（P=0.008），而FMD组中位hs-CRP水平显著降低（P=0.01）。与对照组相比，FMD组的Miller-Payne病理反应分级4/5级（肿瘤细胞丢失率90%~100%）以及术前经MRI或超声评估的影像学完全缓解或部分缓解率更高（P=0.01）。研究结论：化疗期间应用禁食模拟饮食耐受性良好，可降低化疗毒性，并对部分代谢指标产生有益影响。临床试验注册：https://irct.behdasht.gov.ir/user/trial/61386/view