Intermittent Fasting for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thomas Jefferson University

Stay on Your Current Meds

No Placebo Group

Breakthrough Therapy

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies if intermittent fasting can improve outcomes for breast cancer patients with a BMI of 25 or higher who are receiving chemotherapy. The fasting involves not eating for a certain period and eating during another specific period each day. This approach may help control blood sugar and insulin levels, potentially reducing tumor growth. Intermittent fasting has been studied for its potential benefits in weight loss and managing cardiometabolic risk factors.

Research Team

Eligibility Criteria

This trial is for adults over 18 with stage I-III breast cancer and a BMI of at least 25. They must have HER2 negative tumors, low hormone receptor positivity, and be eligible for standard pre-surgery chemotherapy. Patients with small multifocal cancers or limited metastatic disease may also qualify if they're planning to undergo the same chemo.

Inclusion Criteria

My tumor is HER2 negative according to specific guidelines.

My breast tumor is at least 1.5 cm or I have cancer in my underarm lymph nodes.

I have more than one breast cancer spot, all meeting the same ER/PR and HER2 criteria.

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Treatment Details

Interventions

Chemotherapy (Chemotherapy)
Short-Term Fasting (Behavioural Intervention)

Trial OverviewThe study is testing whether intermittent fasting can improve outcomes in patients receiving chemotherapy before surgery for breast cancer. It's based on evidence that fasting might help reduce blood sugar levels, increase insulin sensitivity, and slow down tumor growth.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (Intermittent Fasting)Experimental Treatment1 Intervention

Patients undergo intermittent fasting involving 14 hours of fasting and 10 hours of eating for approximately 4 months while undergoing standard of care neoadjuvant chemotherapy. Acceptable neoadjuvant chemotherapy regimen includes doxorubicin and cytoxan followed by paclitaxel (AC-T). The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician.

Chemotherapy is already approved in Canada, Japan, China, Switzerland for the following indications: