CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
• Pathologically proven invasive breast cancer
• Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist
• The patient must be female
• Age ≥ 18
• Non-metastatic and non-inflammatory breast cancer
• History/physical examination, including breast exam and documentation of weight and Karnofsky Performance Status of 80-100% for at least 60 days prior to study entry.
• Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during chemotherapy
• Patient must capable of and provide study specific informed consent prior to study entry
• BMI ≥21
• Weight ≥120lbs
• No prior history of non-breast malignancies in the past 1 year unless it was a non- melanomatous skin lesion or carcinoma in situ of the cervix.
• Patient must not have Acquired Immune Deficiency Syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism.
• Patient may not have any active Gastrointestinal/Malabsorption disorder at the discretion of the Principal Investigator which may include:
• Chronic Pancreatitis
• Chronic Diarrhea or Vomiting
• Active Eating Disorder
• No history of or current active drug/alcohol dependence.
• No patients with decisional impairment.