Neoadjuvant Breast Cancer Time Restricted Eating
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast Ductal Carcinoma in SituInvasive Breast CarcinomaAnatomic Stage I Breast Cancer AJCC v8HER2 Negative Breast CarcinomaHormone Receptor Positive Breast Carcinoma
- Interventions
- Other: Short-Term Fasting
- Registration Number
- NCT05327608
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+/- 5 days) by the research team during their clinic visit.
- Detailed Description
Primary objective:
1. To evaluate the proportion of patients that can adhere to Time Restricted Eating (TRE) in patients with HER2 negative breast cancer who receive neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer.
Secondary objectives:
1. To evaluate the pathologic complete response (pCR) rate of TRE in patients with HER2 negative breast cancer who receive NCT for a new diagnosis of stage I-III breast cancer
2. To evaluate the effect of TRE on weight management (prevention of weight gain), measured by BMI and waist circumference, in patients who are undergoing NCT.
3. To evaluate the percent of patients who develop CTCAE version 5.0 grade 3 or 4 toxicities
4. To evaluate the differences in the pCR rate among breast cancer patients within different race/ethnic groups, African American vs. Non-Hispanic White (AA vs NHW), and based on baseline social determinants of health when undergoing NCT
5. To evaluate if study intervention acceptability, adherence, and engagement differ by race (AA vs NHW) and based on baseline social determinants of health.
6. 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 objectives:
1. To monitor changes in the following inflammatory markers in patients undergoing neoadjuvant chemotherapy with TRE: fasting glucose, hemoglobin A1c, insulin, C-peptide, CRP, leptin, adiponectin,IGF-1, IL-6, TNF-α, and free fatty acids and lipids
2. 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. For this analysis we will use on tissue from baseline diagnostic tissue biopsies and post TRE plus neoadjuvant chemotherapy surgical tissue resection, when available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (Intermittent Fasting) Short-Term 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. Acceptable neoadjuvant chemotherapy 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.
- Primary Outcome Measures
Name Time Method 1. Proportion of patients who can adhere to time restricted eating (TRE) >= 70% of days While undergoing neoadjuvant chemotherapy A patient's adherence will be measured as the percent (%) of days where a patient reports on the survey that they were able to complete at least 14 or more hours of fasting per 24 hours (each day) during 16 weeks (112 days) of neoadjuvant chemotherapy. A patient will be considered adherent to TRE if percent (%) of days where a patient reports on the survey that they were able to complete at least 14 or more hours of fasting per 24 hours (each day) during 16 weeks is 70% or higher. For patients who complete \< 16 weeks of chemotherapy from the date of starting TRE, adherence will be computed based on number of days of chemotherapy cycles received. If the proportion of days with confirmed TRE adherence is 70% or greater, then the patient is considered to have achieved overall TRE adherence.
- Secondary Outcome Measures
Name Time Method To measure the percent of patients who develop CTCAE (v5.0) grade 3 of 4 toxicities 4 months percent of patients who develop CTCAE (v5.0) grade 3 of 4 toxicities
Pathologic complete response (pCR) rate 4 months Will be estimated with corresponding the exact binomial 90% confidence intervals.
To measure the percent of patients who maintain or have a reduced BMI and waist circumference after TRE and neoadjuvant chemotherapy. 4 months percent of patients who maintain or have a reduced BMI and waist circumference after TRE and neoadjuvant chemotherapy.
To compare pCR rate among African American vs. Non-Hispanic White breast cancer patients and based on social determinants of health when undergoing TRE plus neoadjuvant chemotherapy. 4 months pCR rate among African American vs. Non-Hispanic White breast cancer
To measure the acceptability, adherence, and engagement of TRE among African American vs. Non-Hispanic White breast cancer patients and based on social determinants of health when undergoing neoadjuvant chemotherapy. 4 months The acceptability, adherence and engagement of TRE among African American vs. Non-Hispanic white breast cancer patients will be measured by the percent (%) of days where a patient reports on the survey that they were able to complete at least 14 days or more hours of fasting per 24 hours ( each day) during 16 weeks ( 112 days) of neoadjuvant chemotherapy.
To evaluate if percent of patients with CTCAE (v5.0) grade 3 or 4 toxicities differs among African American vs. Non-Hispanic White breast cancer patients and based on social determinants of health when undergoing TRE plus neoadjuvant chemotherapy. 4 months percent of patients with CTCAE (v5.0) grade 3 or 4 toxicities differs among African American vs. Non-Hispanic White breast cancer patients and based on social determinants of health when undergoing TRE plus neoadjuvant chemotherapy.
Trial Locations
- Locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States