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

Sponsor

Thomas Jefferson University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05327608

Collaborator

(none)

Enrollment

Location

Arm

21.1

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II 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.

Condition or Disease	Intervention/Treatment	Phase
Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Breast Ductal Carcinoma in Situ HER2 Negative Breast Carcinoma Hormone Receptor Positive Breast Carcinoma Invasive Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8	Other: Short-Term Fasting Other: Chemotherapy	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

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:

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.
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.
To evaluate the differences in the pCR rate among breast cancer patients within different ethnic groups, African American versus (vs.) Non-Hispanic White (AA vs NHW) undergoing NCT.
To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW).
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).

EXPLORATORY OBJECTIVES:

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.
To perform a reverse-phase protein microarrays (RPPA) analysis on tissue from baseline diagnostic tissue biopsy pre- and post-intermittent fasting plus neoadjuvant chemotherapy surgical tissue resection, when available, for the following biomarkers that measure the adipocyte and tumor microenvironment of metabolic, lipogenic signaling pathways and adipokine and cytokine signaling architecture.

OUTLINE:

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 28, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (Intermittent Fasting) Patients undergo intermittent fasting involving 14 hours of fasting and 10 hours of eating for approximately 4 months while undergoing standard of care neoadjuvant chemotherapy.	Other: Short-Term Fasting Undergo intermittent fasting Other Names: Intermittent Fasting Short-term Intermittent Fasting Other: Chemotherapy Receive standard of care neoadjuvant chemotherapy

Arm

Intervention/Treatment

Experimental: Treatment (Intermittent Fasting)

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

Other: Short-Term Fasting

Undergo intermittent fasting

Other Names:

Intermittent Fasting

Short-term Intermittent Fasting

Other: Chemotherapy

Receive standard of care neoadjuvant chemotherapy

Outcome Measures

Primary Outcome Measures

Proportion of patients who can adhere to to intermittent fasting > 80% of days [Through study participation; approximately 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient must be >= 18 years of age at time of consent and must be able to understand and provide informed consent
BMI >= 25 at time of enrollment
Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma
Multifocal or contralateral ductal carcinoma in situ (DCIS) or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER/PR and HER2
Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
Tumor status must be HER2 negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (determined by local testing)
ER and PR expression must be < 10% cells positive by immunohistochemestry (IHC) test
Patients must have clinical stage I-III (utilizing tumor, node, metastasis [TNM] criterion) at diagnosis
Clinical T size must be >= 1.5 cm
Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy

Acceptable regimen includes doxorubicin and cytoxan followed by paclitaxel (ACT; regimen can be standard or dose dense). Carboplatin cannot be added to the neoadjuvant chemotherapy regimen

Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician
Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention

Exclusion Criteria:

Clinical T4 and/or N3 disease, including inflammatory breast cancer
Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy
Use of carboplatin in the neoadjuvant chemotherapy regimen
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention
Patients must not have impaired decision-making capacity
Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool and behavioral lifestyle coaching in English
Patients that are > 2 weeks into starting neoadjuvant chemotherapy regimen