An interventional study of Time restricted eating in Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Neoplasm Female and Breast Cancer, sponsored by University of Illinois at Chicago. Recruiting at 2 sites in United States. Open to female participants aged 25 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
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. We will test 3 different eating window options compared to a control group for 24 weeks.
Little is known about how nutrition therapy can affect breast cancer treatment outcomes. Current standard care suggests enough daily calories and protein to maintain body weight and avoid muscle loss. However, this approach may be antiquated given weight gain is common during treatment and emerging pre-clinical and clinical evidence suggest that fasting during chemotherapy may improve clinical and patient-reported outcomes. For example, preliminary human trials examining the fasting mimicking diet (very low-calorie, low-protein diet 1-week per month) or short-term fasting (48-120 hours (h)), known as periodic fasting, surrounding chemotherapy may increase effectiveness of treatment and decrease side effects related to chemotherapy. Yet these diets have low adherence, side effects of their own, and may increase patient burden and decrease quality of life. In contrast, time restricted eating (TRE) is a form of intermittent fasting with high adherence that may have similar positive effects on treatment outcomes without the untoward side-effects. Moreover, TRE may have beneficial effects on glucose regulation and body composition (i.e., decreased weight and body fat gain) suggesting the potential importance of this regimen to breast cancer recurrence. TRE is extremely accessible with no calorie counting or financial burden to the patient, individuals just shorten their eating window daily.
The aim of this trial is to examine the feasibility and acceptability of 24-weeks of 8-h TRE among female breast cancer patients initiating chemotherapy. Additionally the preliminary effect of 8-h TRE on treatment outcomes, treatment related side-effects, and patient reported quality of life and fatigue will be explored. Exploratory outcomes will include glucose regulation, body weight, body composition, IGF-1, IGFBP3, SHBG, estradiol (e2), TNF-alpha, and hsCRP
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society.
Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.
Behavioral: Time restricted eating
Participants assigned to this arm will follow the 8-h TRE protocol. Participants will consume food ad libitum (no calorie or food restrictions) during a self-selected 8-h eating window (beginning at 10:00 am, 11:00am, or 12:00 pm) and fasting for 16 hours daily. They will follow this same eating pattern for the length of the intervention. Calorie free drinks such as water, black coffee, and diet soda, are permitted during the fasting period. The eating window will allow for a typical breakfast/lunch/dinner eating pattern.
Also known as: TRE
Recruitment feasibility
women eligible and referred by staff to the research team. We will also track the number of referred women approached (by phone \& in person) by our research team for screening/enrollment and the number of women who decline and their reasons for non-enrollment
Time frame: 24 weeks
TRE Acceptibility
attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored
Time frame: 24 weeks
TRE adherence
Diet adherence will be monitored either by patient reported start and stop times of food intake and diet pattern scoring and will be assessed by the study coordinator with a total score of 7 days per week followed by a post intervention qualitative survey.
Time frame: 24 weeks
Quality of Life
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
Time frame: 24 weeks
Fatigue
The Functional assessment of Cancer therapy - fatigue
Time frame: 24 weeks
Treatment related side effects
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE
Time frame: 24 weeks
Biochmical blood count Safety
CBC
Time frame: 24 weeks
Change in Insulin
Time frame: 24 weeks
Change in glucose
Time frame: 24 weeks
Change in HbA1c
Time frame: 24 weeks
Change in TNF-alpha
Time frame: 24 weeks
Change in body weight
Time frame: 24 weeks
Change in fat mass
Time frame: 24 weeks
Change in lean mass
Time frame: 24 weeks
Change in visceral adiposity
Time frame: 24 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 10 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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