What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, can cause side effects including fatigue, nausea, vomiting, hair loss, and increased infection risk. Hormonal therapies may lead to hot flashes, joint pain, and blood clots, while targeted therapies can cause diarrhea, liver issues, and skin rashes. Radiation therapy often results in skin irritation, fatigue, and localized pain.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer that target similar mechanisms to those being studied in the intermittent fasting trial. For instance, alpelisib, a PI3K inhibitor, is approved for use with fulvestrant in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. This drug works by targeting the PI3K pathway, which is involved in cell growth and metabolism, potentially improving insulin sensitivity and reducing tumor growth. Additionally, other endocrine therapies and targeted agents like everolimus have been approved for hormone receptor-positive breast cancer, focusing on similar pathways to manage the disease.

What other types of research exist?

Promising alternatives to intermittent fasting for breast cancer patients include: 1) Exercise interventions, which improve insulin sensitivity and reduce insulin levels. 2) Low-fat dietary modifications, which have been associated with better outcomes. 3) Sustained weight loss strategies, which can reduce breast cancer risk. 4) Medical nutrition therapy to manage blood glucose levels and enhance metabolic health.

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Chemotherapy

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

N/A

Waitlist Available

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be >= 18 years of age at time of consent and must be able to understand and provide informed consent

Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Intermittent fasting could lead to side effects like fatigue, weakness, dizziness due to low blood sugar or dehydration. Some individuals might experience digestive issues such as constipation or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older and can understand and agree to the study's requirements.

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I have been recently diagnosed with invasive breast cancer.

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My tumor is HER2 negative according to specific guidelines.

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My cancer tests show less than 10% of cells are ER and PR positive.

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My cancer was stage I-III when first diagnosed.

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

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I am willing and able to undergo at least 16 weeks of chemotherapy before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who can adhere to to intermittent fasting

Secondary study objectives

Adherence of Intermittent fasting among African American vs. Non-Hispanic White breast cancer patients

Incidence of adverse events

Pathologic complete response (pCR) rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, such as chemotherapy, hormone therapy, and targeted therapy, work through various mechanisms to inhibit tumor growth and spread. Chemotherapy targets rapidly dividing cells, causing cell death, while hormone therapy blocks hormones like estrogen that fuel certain breast cancers. Targeted therapies focus on specific molecules involved in cancer growth, such as HER2. Intermittent fasting, as studied in recent trials, may complement these treatments by reducing blood glucose levels, improving insulin sensitivity, and directly inhibiting tumor cell growth. These metabolic changes are crucial as they can enhance the effectiveness of conventional treatments and potentially reduce cancer recurrence, offering a holistic approach to managing breast cancer.