Overview
This study will examine if a short-term, reduced protein diet for the 3-day period prior to and on the day of each of the first 4 chemotherapy cycles and 4 days prior to primary breast surgery is well tolerated and adhered to by patients with stage II or III estrogen receptor positive (ER+) human epidermal growth factor receptor negative (HER2-) breast cancer (BC) receiving neoadjuvant chemotherapy (NAC).
Description
There has been recent interest in the potential anti-cancer effects of nutrition interventions, although little is known about how individual patients' diets can impact the tumor microenvironment, and potentially patient outcomes. This is despite long-standing patient and healthcare provider interest in this type of adjunctive therapy. Therein lies a significant opportunity to develop nutritional recommendations that could exert antitumor effects with minimal, if any, side effects. To meet this opportunity, dietary alterations in cancer patients have been implemented in a surprisingly small number of studies, including the use of ketogenic and fasting-mimicking diets. Although findings from these trials suggest some modest benefit, such extreme alterations proved difficult for patients to adhere to, thus making them impractical for wide-spread use. Studies in humans show that high protein intake significantly increases the likelihood of dying from cancer, and work in rodents shows that feeding a high protein diet enhances carcinogenesis, suggesting that limiting protein intake may have anticancer benefits. Accordingly, investigators at Stony Brook University and others have shown that reducing protein consumption slows tumor growth, enhances anti-tumor immunity and improves the efficacy of anticancer therapy in murine models. These effects likely result from restricting the availability of tumor growth promoting amino acids. However, the impact of lowering protein intake on the biology of patients' tumors is unknown.
Investigators at Stony Brook University have already established a method to reduce protein intake in healthy humans demonstrating strong adherence and correlated biological changes. Positive findings from this trial would justify larger scale randomized controlled feeding trials to evaluate clinical outcomes including pathologic response, treatment tolerance, immune cell infiltration, and overall survival with this intervention. This line of investigation has the potential to provide the first evidence that intermittent dietary protein reduction is a safe, low-cost method to impede tumor growth, optimize response to anti-tumor therapies and improve patient outcomes.
Eligibility
Inclusion Criteria:
- 18-75 years of age at time of consent
- Stage II or III ER+ HER2- breast cancer patients scheduled to receive standard of care neoadjuvant chemotherapy
- Willingness to consume study foods exclusively during the 20 days of prescribed diet
Exclusion Criteria:
- Any food allergy that may result in anaphylactic response or death (due to possible food allergen cross-contamination in the metabolic kitchen)
- Habitual low protein intake, less than or equal to 1.0 g per kilogram adjusted body weight, based on a screening dietary habits questionnaire score
- Vegans or vegetarians that consume dairy and or eggs
- Pregnant or breastfeeding at the time of screening
- Significant mental illness presenting challenges to follow directions and consume the controlled protein diet exclusively
- Body mass index less than or equal to 18 kilograms over meter squared or greater than 35 kilograms over meter squared
- Participating in another study with a diet intervention
