15 Participants NeededMy employer runs this trial

Dietary Protein Intervention for Breast Cancer

SB
Overseen ByStony Brook Cancer Cetner Clinical Research Office
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Josephine Connolly-Schoonen
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a short-term, reduced protein diet is manageable for people with certain types of breast cancer undergoing chemotherapy. It targets patients with stage II or III estrogen receptor positive (ER+) breast cancer, where cancer grows in response to estrogen. The trial aims to determine if these patients can adhere to this diet plan before and during chemotherapy cycles and before surgery. This trial may suit those diagnosed with ER+ breast cancer, preparing for chemotherapy, and willing to follow a specific diet during treatment days. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance dietary guidelines during cancer treatment.

What prior data suggests that this dietary protein intervention is safe for breast cancer patients?

Research has shown that reducing protein intake at specific times during chemotherapy is generally safe and can help lessen treatment side effects. Studies have found this diet plan to be both feasible and well-received by patients. It has eased some common chemotherapy side effects. No major reports of serious issues have emerged from this dietary change, making it a promising option for those undergoing breast cancer treatment.12345

Why are researchers excited about this trial?

Most treatments for breast cancer focus on chemotherapy, surgery, and radiation to target and destroy cancer cells. However, the Dietary Protein Intervention is unique because it involves adjusting dietary protein intake around chemotherapy and surgery. This approach aims to enhance the effectiveness of these treatments by potentially reducing side effects and improving recovery. Researchers are excited about this method because, unlike standard treatments, it explores how diet can play a role in cancer care, potentially offering a new, non-invasive way to support traditional therapies.

What evidence suggests that this dietary protein intervention is effective for breast cancer?

Research has shown that reducing protein intake might slow tumor growth and enhance the effectiveness of cancer treatments. In one study, tumors shrank by 56% with reduced protein consumption. Another study found that dietary changes can lower inflammation markers, such as C-reactive protein (CRP), which are often linked to cancer progression. This trial will investigate an intermittent reduced dietary protein intervention, where participants will follow a reduced protein diet during specific periods around their chemotherapy cycles and before surgery. This diet is considered safe and may enhance chemotherapy effectiveness for breast cancer patients. These findings suggest that eating less protein could benefit those undergoing treatment for ER+ (estrogen receptor positive) and HER2- (human epidermal growth factor receptor negative) breast cancer.678910

Who Is on the Research Team?

JC

Josephine Connolly-Schoonen, PhD, RD

Principal Investigator

Stony Brook University - Family, Population and Preventive Medicine

Are You a Good Fit for This Trial?

This trial is for people with stage II or III breast cancer that is estrogen receptor positive (ER+) and HER2 negative, who are about to start chemotherapy before surgery.

Inclusion Criteria

I am between 18 and 75 years old.
I have stage II or III ER+ HER2- breast cancer and will get chemotherapy before surgery.
Willingness to consume study foods exclusively during the 20 days of prescribed diet

Exclusion Criteria

Vegans or vegetarians that consume dairy and/or eggs
Significant mental illness presenting challenges to follow directions and consume the controlled protein diet exclusively
Any food allergy that may result in anaphylactic response or death due to possible food allergen cross-contamination in the metabolic kitchen
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant chemotherapy with an intermittent, reduced protein diet for 3 days prior to and on the day of each of the first 4 chemotherapy cycles

12 weeks
4 chemotherapy cycles, each 21 days apart

Preoperative Evaluation

Participants undergo evaluation and dietary intervention 4 days prior to primary breast surgery

4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-operative complications and dietary adherence

1 month
Post-surgery follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Dietary Protein Intervention

Trial Overview

The study tests if eating less protein for a few days around each of the first four chemo sessions and before surgery is safe and doable for these breast cancer patients. All participants receive standard chemotherapy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intermittent Reduced Dietary Protein InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Josephine Connolly-Schoonen

Lead Sponsor

Citations

The Effects of Protein Restricted Diet and Physical Activity on ...

It was demonstrated that the group with the 7% isocaloric protein restriction exhibited a 56% reduction in tumor size compared to the group ...

Short-Term Reduced Dietary Protein in ER+/HER2- Breast ...

intermittent dietary protein reduction is a safe, low-cost method to impede tumor growth, optimize response to anti-tumor therapies and improve ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40814965/

Long-Term Effectiveness of Dietary Interventions on ...

Results: A total of 11 trials were included in the meta-analysis. Adherence to a healthy diet significantly decreased C-reactive protein (CRP) levels compared ...

Breast Cancer Patients During Neoadjuvant Chemotherapy

Safety of an intermittent, reduced protein diet - frequency of dose reduction or delay in chemotherapy, Number of episodes of dose reductions or delays in ...

Randomised controlled trial of intermittent vs continuous ...

Dietary fat reduction and breast cancer outcome: interim efficacy results from the Women's Intervention Nutrition Study. J Natl Cancer Inst.

Intermittent Fasting in Breast Cancer: A Systematic Review ...

Notably, IF during chemotherapy was found to be feasible, safe and able to relieve chemotherapy-induced adverse effects and cytotoxicity. IF seemed to improve ...

Nutrition Intervention May Improve Survival in Women With ...

After a median 5-year follow-up, researchers saw a 9.2% reduction in fat calories and a 6-pound reduction in weight in the dietary intervention ...

Exploring the Feasibility, Acceptability, and Safety of a 4:3 ...

This study aimed to examine feasibility, acceptability, and safety of a 4:3 IMF intervention among breast cancer survivors. have OW/OB,

Diet and Breast Cancer Risk | Breast ...

Broader clinical studies suggest that up to 50-70% of breast cancers could potentially be prevented, depending on when lifestyle modifications are adopted.

Low-Fat Diet Reduces Mortality in Breast Cancer Subset

In women with estrogen receptor (ER)-negative tumors, a 36% statistically significant reduction in deaths was seen with intervention. The ...