Description:
This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total
carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur
at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported
outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at
their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of
the intervention. All subjects will receive surgery after approximately 6 months of
intervention. Total duration of the study is expected to be 2 years, though each patient's
participation will be approximately 6 months.
Title
- Brief Title: NEOBREADS: Neoadjuvant Breast Diet Study
- Official Title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
Clinical Trial IDs
- ORG STUDY ID:
IIT2018-25-MITA-NEOBREADS
- NCT ID:
NCT03822715
Conditions
Interventions
Drug | Synonyms | Arms |
---|
standard of care aromatase inhibitors | | Dietary intervention |
Purpose
This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total
carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur
at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported
outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at
their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of
the intervention. All subjects will receive surgery after approximately 6 months of
intervention. Total duration of the study is expected to be 2 years, though each patient's
participation will be approximately 6 months.
Trial Arms
Name | Type | Description | Interventions |
---|
Dietary intervention | Experimental | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors | - standard of care aromatase inhibitors
|
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed breast cancer; clinical T2-T4c, any N, M0 invasive breast
cancer by AJCC 7th edition clinical staging, with goal being surgery to complete
excision of tumor in the breast and lymph node. Primary tumor must be palpable,
largest diameter >2.0 cm by physical examination or by radiological assessment.
- ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells
- HER2 Negative; HER2 negative is defined by the following criteria:
1. 0 or 1+ by IHC and ISH not done
2. 0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2
3. 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
- Ability to read, write, and understand English
- BMI >24 kg/m2
- ECOG performance status 0-2
- Planning to receive neoadjuvant aromatase inhibitor therapy
- Written informed consent obtained from subject and ability for subject to comply with
the requirements of the study.
- Age > 18 years
Exclusion Criteria:
- Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates
per day) or vegetarian diet
- Medical comorbidities that in the opinion of the investigator limits the patient's
ability to complete this study
- Candidate for chemotherapy or HER2 directed therapy
- Treatment for this cancer including surgery, radiation therapy, chemotherapy,
biotherapy, hormonal therapy, or investigational agent prior to study entry
(initiation of AI within 30 days of diet initiation acceptable)
- Loss of >10% of body weight within the previous 6 months
- Clinical or radiographic evidence of metastatic disease.
- Current use of weight loss medications including herbal weight loss supplements or
enrolled in a diet/weight loss program
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Diet adherence |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if <20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient <20% of calories were obtained from carbohydrates). |
Secondary Outcome Measures
Measure: | Change in tumor size |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Difference in change in tumor size between pre- and post-intervention between carbohydrate restricted and control group. |
Measure: | Mean change in Ki67 |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in Ki67 between pre-and post- intervention |
Measure: | Mean change in weight |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in weight between pre- and post- intervention |
Measure: | Mean change in HbA1c |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in HbA1c between pre- and post- intervention |
Measure: | Mean change in insulin |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in insulin between pre- and post- intervention |
Measure: | Mean change in triglycerides |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in triglycerides between pre- and post- intervention |
Measure: | Mean change in LDL cholesterol |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in LDL cholesterol between pre- and post- intervention |
Measure: | Mean change in HDL cholesterol |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in HDL cholesterol between pre- and post- intervention |
Measure: | Mean change in total cholesterol |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Change in total cholesterol between pre- and post- intervention |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | Monica Mita |
Trial Keywords
- aromatase inhibitor
- carbohydrate restricted diet
- neo-adjuvant treatment
- low-carb diet
- low carb diet
Last Updated
September 1, 2021