Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Invasive Breast Carcinoma
Conditions
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.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the proportion of patients that can adhere to TRE in patients with early stage 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 TRE in patients with early stage breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. II. To evaluate the effect of TRE in the weight management (prevention of weight gain), measured by BMI and waist circumference, in patients who are undergoing neoadjuvant chemotherapy. III. To evaluate the percent of patients who develop Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 3 or 4 toxicities IV. 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. V. To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW) and based on baseline social determinants of health. VI. To evaluate if percent of patients with CTCAE version 5.0 grade 3 or 4 toxicities differ by race (AA vs NHW) and based on baseline social determinants of health. EXPLORATORY OBJECTIVE: I. To monitor changes in the following inflammatory markers in patients undergoing neoadjuvant chemotherapy with TRE: fasting glucose, hemoglobin A1c, insulin, C-peptide, C-reactive protein (CRP), leptin, adiponectin, insulin-like growth factor 1 (IGF-1), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and free fatty acids and lipids. OUTLINE: 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. After completion of study treatment, patients are followed up for 6 months.
Interventions
OTHERShort-Term Fasting
Undergo TRE
DRUGChemotherapy
Receive standard of care neoadjuvant chemotherapy
PROCEDUREBiospecimen Collection
Undergo blood sample collection
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent * BMI 25-40 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
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days | While undergoing neoadjuvant chemotherapy | The proportion of patients that adhere to TRE will be estimated with the corresponding exact binomial 90% confidence interval. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pCR) rate | Up to 4 months | Will be estimated with corresponding the exact binomial 90% confidence intervals. |
| Percent of patients who maintain or have a reduced body mass index and waist circumference | Up to 4 months | Will be estimated with corresponding the exact binomial 90% confidence intervals. |
| Percent of patients who develop grade 3 or 4 toxicities | Up to 4 months | Will be assessed using Common Terminology Criteria for Adverse Event (CTCAE) version (v) 5.0. |
| Social determinants of health | Up to 4 months | Will be summarized descriptively for the entire study population and separately by the treatment received. |
| pCR rate among Non-Hispanic White patients | Up to 4 months | Will be tabulated estimated with corresponding the exact binomial 90% confidence intervals for entire study population and separately by the treatment received. |
| Acceptability, adherence, and engagement of TRE among African American versus Non-Hispanic White breast cancer patients | Up to 4 months | — |
| Incidence of adverse events | Up to 4 months | Will assess percent of patients with CTCAE v5.0 grade 3 or 4 toxicities differs among African American versus non-Hispanic White breast cancer patients. |
Countries
United States
Contacts
CONTACTSite Public Contact
PRINCIPAL_INVESTIGATORMaysa Abu-Khalaf, MD, MBA
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Outcome results
None listed