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Intermittent Fasting for Breast Cancer
N/A
Waitlist Available
Led By Sailaja Kamaraju, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Breast cancer patients ≥ 18 years old who are willing to consent to an approximately 14-hour nighttime fasting period and an approximately 10-hour daytime eating period
Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive (ER+) and human epidermal growth factor receptor (HER) 2 negative (HER2-) localized breast cancer (stages I-III)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
Study Summary
This trial tests if fasting can make cancer patients feel better while on treatment.
Who is the study for?
This trial is for women over 18 with HR+/HER2- early breast cancer who are starting or already on adjuvant endocrine therapy. They must have a BMI of at least 25 and be willing to follow a specific intermittent fasting schedule. Participants should not be pregnant, breastfeeding, or planning to conceive during the study. Those with certain health conditions like diabetes, eating disorders, or uncontrolled heart disease cannot join.Check my eligibility
What is being tested?
The trial is testing if a six-month intermittent fasting program can improve quality of life and reduce inflammation in women undergoing treatment for early-stage breast cancer. It's designed to see if patients can stick to the fasting routine and how it affects their well-being while they're also taking hormone therapy.See study design
What are the potential side effects?
Intermittent fasting may lead to side effects such as dizziness, low blood sugar (hypoglycemia), fatigue due to changes in diet patterns, potential nutrient deficiencies if not properly managed, and possible exacerbation of pre-existing conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, have breast cancer, and agree to follow a specific eating and fasting schedule.
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My breast cancer is ER+ and HER2-.
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I can take care of myself and am up and about more than half of my waking hours.
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My breast cancer is hormone receptor positive and HER2 negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subject adherence to the intermittent fasting schedule.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intermittent FastingExperimental Treatment1 Intervention
Enrolled subjects are expected to start the study intervention after completion of definitive therapy and within three months of starting AET.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittent Fasting
2016
N/A
~500
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,693 Total Patients Enrolled
14 Trials studying Breast Cancer
409,453 Patients Enrolled for Breast Cancer
Sailaja Kamaraju, MDPrincipal InvestigatorMedical College of Wisconsin
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available slots for participants in this research endeavor?
"According to clinicaltrials.gov, this research project is no longer enrolling participants - the initial post was made on January 15th 2024 and the last update happened on October 24th 2023. Nonetheless, there are still 3093 other studies that require volunteers at this time."
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