Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT07387445
Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.
A study testing Time restricted eating in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Neoplasm Female, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 99 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Neoplasm Female, Breast Cancer
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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 efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Kelsey Gabel, RD PhD, (312) 413-8911, fastlab@uic.edu
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Kelsey Gabel, RD, PhD, 312-413-8911, kdipma2@uic.edu
About this study
Official title: Time Restricted Eating During Chemotherapy for Breast Cancer
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.
Read the detailed description
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
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Neoplasm Female, Breast Cancer
- Being tested
- Time restricted eating
- Keywords
- breast cancer, fasting, intermittent fasting, time restricted eating, chemotherapy initiation
- Medical subject headings
- Breast Neoplasms, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Also called TRE
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care control | No intervention | Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society. |
| 8-h TRE | Experimental | 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. Receives: Behavioral: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 24 weeks
Secondary outcomes (12)
Quality of Life
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
Measured: 24 weeks
Fatigue
The Functional assessment of Cancer therapy - fatigue
Measured: 24 weeks
Treatment related side effects
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, PRO-CTCAE
Measured: 24 weeks
Biochmical blood count Safety
CBC
Measured: 24 weeks
Change in Insulin
Measured: 24 weeks
Change in glucose
Measured: 24 weeks
Change in HbA1c
Measured: 24 weeks
Change in TNF-alpha
Measured: 24 weeks
Change in body weight
Measured: 24 weeks
Change in fat mass
Measured: 24 weeks
Change in lean mass
Measured: 24 weeks
Change in visceral adiposity
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A 24-week open-label controlled trial will be conducted. Forty women with stage I-IV breast cancer initiating chemotherapy will be recruited. Women will be assigned to 8-h TRE (self-selected start at 10am, 11am, or 12pm) ad-libitum eating during a 24-week self-selected 8 hour eating window and fasting 16- hours daily, or standard care for 24 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelsey Nicole Dipman Gabel, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387445
- Sponsor's protocol ID
- Study2021-0974
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating During Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT07387445
- Acronym / sponsor ID
- Study2021-0974
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Neoplasm Female, Breast Cancer
- Keywords
- breast cancer, fasting, intermittent fasting, time restricted eating, chemotherapy initiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A 24-week open-label controlled trial will be conducted. Forty women with stage I-IV breast cancer initiating chemotherapy will be recruited. Women will be assigned to 8-h TRE (self-selected start at 10am, 11am, or 12pm) ad-libitum eating during a 24-week self-selected 8 hour eating window and fasting 16- hours daily, or standard care for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Standard Care control | No intervention | –Participants assigned to standard care will follow the recommendations by American Association for Cancer Research and the American Cancer Society. |
| 8-h TRE | Experimental | Behavioral: Time restricted eatingParticipants 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. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingAlso: TREParticipants 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. | Behavioural | 8-h TRE |
Primary outcome
Recruitment feasibility
Time frame: 24 weeks
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
TRE Acceptibility
Time frame: 24 weeks
attendance at study visits, completeness of data, and overall and treatment specific loss to follow-up/withdrawal will be closely monitored
TRE adherence
Time frame: 24 weeks
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.
12 secondary outcomes
Quality of Life
Time frame: 24 weeks
Fatigue
Time frame: 24 weeks
Treatment related side effects
Time frame: 24 weeks
Biochmical blood count Safety
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Neoplasm Female, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Gabel, RD, PhD (312-413-8911, kdipma2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.