Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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:
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
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal