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Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy

A Pilot Trial of Controlled Feeding With Reduced Dietary Protein in Patients With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Receiving Neoadjuvant Chemotherapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

NY