Intermittent Fasting for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title: Intermittent Fasting for Patients With HER2- Negative and ER/PR <10% Breast Cancer and Body Mass Index >= 25 Receiving Neoadjuvant Chemotherapy

Status Suspended

Clinical Trial Summary

This trial studies whether intermittent fasting works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index >= 25. Intermittent fasting has been shown to elicit similar metabolic changes as calorie restriction such as reduction in blood glucose levels, improved insulin sensitivity, and reduction of tumor cell growth. Intermittent fasting may improve outcomes in patients with breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To evaluate the proportion of patients that can adhere to intermittent fasting (14:10) in patients with HER2 negative and estrogen receptor (ER)/progesterone receptor (PR) < 10% breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the pathologic complete response (pCR) rate of intermittent fasting (14:10) in patients with HER2 negative and ER/PR < 10% breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer.

II. To evaluate the effect of intermittent fasting in the prevention of weight gain, measured by body mass index (BMI) and waist circumference, in patients who are undergoing neoadjuvant chemotherapy.

III. To evaluate the differences in the pCR rate among breast cancer patients within different race/ethnic groups, African American versus (vs.) Non-Hispanic White (AA vs NHW) and based on baseline social determinants of health when undergoing NCT.

IV. To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW) and based on baseline social determinants of health.

V. To evaluate if percent of patients with Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 3 or 4 toxicities differ by race (AA vs NHW) and based on baseline social determinants of health.

EXPLORATORY OBJECTIVES:

I. To monitor changes in the following inflammatory markers in patients undergoing neoadjuvant chemotherapy with intermittent fasting: fasting glucose, hemoglobin A1c, insulin, leptin, adiponectin, free fatty acids and lipids.

II. To measure changes in markers involved in metabolic and lipogenic signaling pathways, immune modulation, and autophagy in adipocytes, tumor cells, and surrounding immune cells by Reverse-Phase Protein microarrays (RPPA) analysis.

OUTLINE:

Patients undergo intermittent fasting involving 14 hours of fasting and 10 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy.

After completion of study treatment, patients are followed up for 6 months. ;

Related Conditions & MeSH terms

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Ductal Carcinoma in Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• HER2 Negative Breast Carcinoma
• Hormone Receptor Positive Breast Carcinoma
• Invasive Breast Carcinoma

• NCT number: NCT05327608
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Suspended
• Phase: N/A
• Start date: July 28, 2022
• Completion date: May 1, 2024