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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

Study Summary

This trial is testing whether fasting could improve outcomes for obese breast cancer patients receiving chemotherapy.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who can adhere to to intermittent fasting

Secondary outcome measures

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

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

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

444 Previous Clinical Trials

145,569 Total Patients Enrolled

5 Trials studying Breast Cancer

607 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,098 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this investigation currently open?

"Affirmative. Clinicaltrials.gov has information that suggests this experiment is presently enrolling volunteers, with the first posting date being July 28th 2022 and the last update occurring on August 2nd 2022. The research project needs to recruit 55 individuals from a single medical location."

Answered by AI

What is the scope of recruitment for this research endeavor?

"Affirmative. The particulars of this clinical trial, which was posted on July 28th 2022, are listed as active recruitment status according to information hosted on clinicaltrials.gov. This medical study requires the participation of 55 individuals from a single site."

Answered by AI

What risks are associated with undergoing Chemotherapy?

"After careful consideration, the safety rating of chemotherapy was determined to be a 2 due it's status as Phase 2 clinical trial. Thus far, there is sufficient data to suggest that it is safe but not enough evidence to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Intermittent Fasting for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327608.