Recruiting

Reduced Protein Diet

Sponsor:

Josephine Connolly-Schoonen

Code:

NCT07897344

Conditions

Breast Cancer

Hormone Receptor Positive / HER2-negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dietary Protein Intervention

Study Details

Brief summary:

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).

Conditions

Breast Cancer

Hormone Receptor Positive / HER2-negative Breast Cancer

Study ID

NCT07897344

Start date

Nov 2, 2026

Status verified date

Oct, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intermittent Reduced Dietary Protein Intervention

Patients will receive an intermittent, 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.

Interventions

Dietary Protein Intervention

Consume an intermittent, reduced protein diet for a total of 20 feeding days over the course of neoadjuvant treatment (at the time of the first four chemotherapy cycles and prior to surgery)

Primary outcome measure

  • Feasibility of completing the intermittent, reduced protein diet intervention [ Time Frame: Immediately after the intervention/pre-surgery ]
  • Recruitment of patients receiving neoadjuvant chemotherapy for breast cancer into an intermittent, reduced protein diet intervention [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Stony Brook Cancer Cetner Clinical Research Office

631-728-7425CancerClinicalTrials@stonybrookmedicine.edu

Locations

Stony Brook Cancer Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Stony Brook University Cancer Clinical Trials Office

631-728-7425CancerClinicalTrials@stonybrookmedicine.edu

Principal Investigator:

Josephine Connolly-Schoonen, PhD, RD

More Information

Sponsor

Josephine Connolly-Schoonen

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • Diet
  • Protein
  • Breast cancer
  • Hormone Receptor Positive / HER2-negative Breast Cancer
  • Neoadjuvant chemotherapy
  • Estrogen receptor positive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Josephine Connolly-Schoonen on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.