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New treatment option for Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Official title Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.
ClinicalTrials.gov ID: NCT07387445
What this study is testing
- What it's testing
- This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 99, women only
You may be able to join if
- Age 25-99 at time of consent
- English language or Spanish language (based on availability of lab interpreters)
- ECOG 0 or 1
- Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.
- Demonstrates adequate organ function (absolute neutrophil count ≥ 1,500/μL).
You likely can't join if
- Women with type 1 or insulin dependent type 2 diabetes
- Women with BMI \> 45kg/m2 and \< 18.5 kg/m2
- Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- Shift workers
- Women with a history of eating disorders
- Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \>4kg)
See the full eligibility criteria
- Age 25-99 at time of consent
- English language or Spanish language (based on availability of lab interpreters)
- ECOG 0 or 1
- Breast cancer to meet histologically confirmed Stage I-III or Stage IV with Medical Oncology approval.
- Demonstrates adequate organ function (absolute neutrophil count ≥ 1,500/μL).
- All screening labs to be obtained within 30 days prior to registration.
- Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
- Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
- Women with type 1 or insulin dependent type 2 diabetes
- Women with BMI \> 45kg/m2 and \< 18.5 kg/m2
- Women who are pregnant or nursing. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- Shift workers
- Women with a history of eating disorders
- Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss \>4kg)
- Uncontrolled HIV/AIDS or active viral hepatitis
- Any prior malignancy \<5 years, chemotherapy within the last year or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this...
- Breast cancer recurrence classified by the treating medical oncologist
- Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
- Other major comorbidity, as determined by study PI
- Illicit drug use within previous 3 months or excessive use of alcohol (i.e., \> 2 drinks/day)
- Currently participating in Weight Watcher's or another weight loss program, including weight loss medication such as GLP-1 medications.
- Myocardial infarction
- Congestive heart failure
- Chronic hepatitis
- Cirrhosis
- Chronic pancreatitis
- History of solid organ transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.