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乳腺癌患者新辅助化疗期间的模拟禁食饮食:一项随机对照试验研究。

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

作者信息

Bahrami Alireza, Haghighi Shirin, Moghani Mona Malekzadeh, Khodakarim Nastaran, Hejazi Ehsan

机构信息

Department of Clinical Nutrition and Dietetics, School of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of Oncology, Gastroenterology and Liver Disease Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Front Nutr. 2024 Dec 4;11:1483707. doi: 10.3389/fnut.2024.1483707. eCollection 2024.

Abstract

OBJECTIVE

Preclinical 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.

METHODS

Forty-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.

RESULTS

The occurrence of grade III vomiting and neutropenia in the control group was significantly higher than the FMD group ( = <0.001 and = 0.04 respectively). Erythrocytes ( = 0.01) and neutrophils ( = 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 ( = 0.01 and = 0.005, respectively) in the control group between baseline and after cycle 8. While, the median Insulin-like growth factor-1 (IGF1) ( = 0.006) and hs-CRP ( = 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 ( = 0.008), while the median hs-CRP level was significantly lower in FMD group ( = 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 ( = 0.01).

CONCLUSION

Fasting mimicking diet was well tolerated during chemotherapy and reduced toxicity of chemotherapy and also, had beneficial effects of some metabolic parameters.

CLINICAL TRIAL REGISTRATION

https://irct.behdasht.gov.ir/user/trial/61386/view.

摘要

目的

临床前证据表明,虽然禁食可以降低化疗的副作用和毒性,但它会使癌细胞对化疗更敏感。本研究旨在探讨模拟禁食饮食(FMD)在乳腺癌(BC)患者新辅助化疗期间的效果。

方法

44例新诊断的人表皮生长因子受体2阴性(HER2阴性)BC患者被平均随机分为两组(每组22例),在新辅助化疗前及化疗期间3天分别接受模拟禁食饮食(FMD)或常规饮食。每3周重复一次这种FMD,共8个周期。测量并比较疗效、毒性、血液学、代谢和炎症参数。

结果

对照组III级呕吐和中性粒细胞减少的发生率显著高于FMD组(分别为=<0.001和=0.04)。第8周期后,FMD组的红细胞(=0.01)和中性粒细胞(=0.002)计数显著高于对照组。对照组在基线和第8周期后,中位数血糖和中位数胰岛素水平显著升高(分别为=0.01和=0.005)。而FMD组的胰岛素样生长因子-1(IGF1)中位数(=0.006)和高敏C反应蛋白(hs-CRP)中位数(=0.02)水平显著降低。在研究结束时(第8周期后),对照组的中位数血糖水平显著更高(=0.008),而FMD组的中位数hs-CRP水平显著更低(=0.01)。与对照组相比,FMD组术前通过MRI或超声测量的Miller和Payne病理反应4/5(肿瘤细胞丢失90-100%)以及放射学完全或部分反应更频繁发生(=0.01)。

结论

模拟禁食饮食在化疗期间耐受性良好,降低了化疗毒性,并且对一些代谢参数有有益影响。

临床试验注册

https://irct.behdasht.gov.ir/user/trial/61386/view。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5668/11656309/ba99e27b2ed0/fnut-11-1483707-g001.jpg

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