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Chemotherapy
Treatment (Intermittent Fasting) for Breast Cancer
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
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 belowSelect...
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
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 moreTrial 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.
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.
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
457 Previous Clinical Trials
150,121 Total Patients Enrolled
5 Trials studying Breast Cancer
607 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,868 Previous Clinical Trials
41,010,782 Total Patients Enrolled
946 Trials studying Breast Cancer
1,544,013 Patients Enrolled for Breast Cancer
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