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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05327608
• Other study ID #: 21D.625
• Status: Suspended
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 55
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved

• 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 (AC-T). The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician

• 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

• 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

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

Intervention

Other:
• Short-Term Fasting
Undergo intermittent fasting

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who can adhere to to intermittent fasting	Proportion of patients who can adhere to IF >70% of days while undergoing neoadjuvant chemotherapy. IF done in a 14:10 schedule which entails 14 consecutive hours of fasting followed by an allotted 10 consecutive hours for eating. Adherence to IF will be assessed via daily self-reporting questionnaires via Qualtrics. Adherence to IF will be assessed by study staff approximately every 4 weeks (+/- 5 days).	4 months
Secondary	Pathologic complete response (pCR) rate	Will be estimated with corresponding the exact binomial 90% confidence intervals.	4 months
Secondary	Percent of patients who maintain or have a reduced body mass index and waist circumference	Will be estimated with corresponding the exact binomial 90% confidence intervals.	4 months
Secondary	Social determinants of health	Single Screening Tool -EPIC's SDOH	4 months
Secondary	pCR rate among Non-Hispanic White patients	Will be tabulated estimated with corresponding the exact binomial 90% confidence intervals for entire study population and separately by the treatment received.	4 months
Secondary	Adherence of Intermittent fasting among African American vs. Non-Hispanic White breast cancer patients	Adherence to IF will be assessed via daily self-reporting questionnaires via Qualtrics. Adherence to IF will be assessed by study staff approximately every 4 weeks (+/- 5 days). Count of subjects who complete this outcome will be stratified by race/ethnicity	4 months
Secondary	Incidence of adverse events	Will assess percent of patients with Common Terminology Criteria for Adverse Events version 5.0 grade 3 or 4 toxicities differs among African American vs. Non-Hispanic White breast cancer patients	4 months