Time Restricted Eating for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

NCT05327608 | Recruiting DMC

• 2 other identifiers: 21D.625JT 16674
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

Brief Summary

This phase II trial studies whether time restricted eating (TRE) works to improve outcomes in patients with stage I-III breast cancer receiving chemotherapy before surgery (neoadjuvant) with a body mass index (BMI) 25-40. TRE 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. TRE may improve outcomes in patients with breast cancer.

Conditions

Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Invasive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days

  The proportion of patients that adhere to TRE will be estimated with the corresponding exact binomial 90% confidence interval.

  While undergoing neoadjuvant chemotherapy

Secondary Outcomes (7)

• Pathologic complete response (pCR) rate

  Up to 4 months

• Percent of patients who maintain or have a reduced body mass index and waist circumference

  Up to 4 months

• Percent of patients who develop grade 3 or 4 toxicities

  Up to 4 months

• Social determinants of health

  Up to 4 months

• pCR rate among Non-Hispanic White patients

  Up to 4 months

Study Arms (1)

Treatment (TRE)

EXPERIMENTAL

Patients undergo TRE involving 16 hours of fasting and 8 hours of eating for 4 months while undergoing standard of care neoadjuvant chemotherapy. Patients also undergo blood sample collection on study.

Other: Short-Term Fasting; Drug: Chemotherapy; Procedure: Biospecimen Collection; Other: Questionnaire Administration

Interventions

Short-Term Fasting OTHER

Undergo TRE

Also known as: Intermittent Fasting, Short-term Intermittent Fasting

Treatment (TRE)

Chemotherapy DRUG

Receive standard of care neoadjuvant chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Cancer, General

Treatment (TRE)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample, Collection, Biospecimen, Collected, Biospecimen, Collection, Sample, Collection, Specimen, Collection

Treatment (TRE)

Questionnaire Administration OTHER

Ancillary studies

Treatment (TRE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent
• BMI 25-40 at time of enrollment
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma
• \* Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy
• 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
• Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician
• Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks
• 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
• Patient must have a personal email address, an internet-capable device, and the ability/ willingness to read and reply to email every day for the duration of the study

You may not qualify if:

• 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 with type 1 diabetes, or type 2 diabetes treated with insulin
• Patients with a history of eating disorder
• Patients who work on a rotating shift schedule
• 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
• Patients that are \> 2 weeks into starting neoadjuvant chemotherapy regimen

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (5)

Jefferson Cherry Hill Hospital

Cherry Hill, New Jersey, 08002, United States

RECRUITING

Sidney Kimmel Cancer Center Washington Township, , NJ USA

Sewell, New Jersey, 08080, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

MeSH Terms

Interventions

Drug Therapy; Specimen Handling

Intervention Hierarchy (Ancestors)

Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Maysa Abu-Khalaf, MD, MBA

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Site Public Contact

CONTACT

215-600-9151; ONCTrialNow@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: April 14, 2022
• Study Start: July 28, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

US (5)