Breast Cancer FemaleNCT05259410
Time Restricted Eating During Chemotherapy for Breast Cancer
A study testing TRE and MedTRE in people with Breast Cancer Female, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. Read more about this study
- Who is it for?
- Ages 25 to 99 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- TRE and MedTRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Mar 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
- ECOG 0 or 1
- Breast cancer to meet histologically confirmed Stage I-III.
- Demonstrates adequate organ function (absolutely 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.
Who cannot join
- Women with metastatic disease or type 1 or 2 diabetes
- Women with BMI ≥ 40kg/m2 and < 25kg/m2
- Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- Night 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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- Active infection requiring systemic therapy
- Uncontrolled HIV/AIDS or active viral hepatitis
- Pregnant or nursing
- Any prior 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.
- 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 or excessive use of alcohol (i.e., > 2 drinks/day)
- Currently participating in Weight Watcher's or another weight loss program
- Myocardial infarction
- Stroke
- Congestive heart failure
- Chronic hepatitis
- Cirrhosis
- Chronic pancreatitis
- History of solid organ transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Kelsey Gabel, PhD
About this study
Official title: The Safety and Efficacy of Time Restricted Eating Alone or Combined the Mediterranean Diet During Chemotherapy for Breast Cancer
Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.
Read the detailed description
Current standard of care during chemotherapy for breast cancer 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. However TRE also does no address diet quality. The Mediterranean diet has also been shown to improve patient and treatment outcomes in this population. The additive effect might be even more beneficial. Despite the potential benefits, TRE alone or TRE combined with a mediterranean has not been investigated in breast cancer patients during chemotherapy treatment. We aim to test the safety and feasibility of 8-h TRE compared to TRE combined with a mediterranean style diet among female breast cancer patients initiating chemotherapy for stage I-III breast cancer. We further strive to examine the preliminary efficacy of TRE or TRE with the mediterranean diet on treatment related outcomes, treatment related side effects, patient-reported quality of life and fatigue, blood-based metabolic markers and body/weight adiposity compared to the current standard of care.
- Conditions
- Breast Cancer Female
- Being tested
- TRE, MedTRE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREBehavioural
All food eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day.
MedTREBehavioural
A mediterranean style diet will be eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | Participants will eat all food within the same self selected 8 hour window daily. Receives: Behavioral: TRE |
| Standard care | No intervention | Current standard care is to eat enough calories and protein to maintain weight and lean mass. |
| Med TRE | Experimental | Participants will eat a mediterranean style diet within the same self selected 8 hour window daily. Receives: Behavioral: MedTRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility 8-h TRE
enrollment rate
Measured: 12 weeks
Secondary outcomes (7)
Relative dose intensity
dose intensity between groups
Measured: 12 weeks
Treatment side effects
Side effects
Measured: 12 weeks
EROTC quality of life score
quality of life will be measured by EORTC questionnaire at week 1, 6, and 12
Measured: 12 weeks
Body weight change
body weight
Measured: 12 weeks
Body composition
body fat percentage
Measured: 12 weeks
Change in glucose
glucose
Measured: 12 weeks
Change in insulin
insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Aug 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 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 FemaleStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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
- Investigators
- Kelsey Gabel, MS, RD, PhD, Principal investigator, UIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259410
- Sponsor's protocol ID
- 2021-0974
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Time Restricted Eating Alone or Combined the Mediterranean Diet During Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT05259410
- Acronym / sponsor ID
- 2021-0974
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 28 Feb 2022 (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.
Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.
Detailed description
Current standard of care during chemotherapy for breast cancer 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. However TRE also does no address diet quality. The Mediterranean diet has also been shown to improve patient and treatment outcomes in this population. The additive effect might be even more beneficial. Despite the potential benefits, TRE alone or TRE combined with a mediterranean has not been investigated in breast cancer patients during chemotherapy treatment. We aim to test the safety and feasibility of 8-h TRE compared to TRE combined with a mediterranean style diet among female breast cancer patients initiating chemotherapy for stage I-III breast cancer. We further strive to examine the preliminary efficacy of TRE or TRE with the mediterranean diet on treatment related outcomes, treatment related side effects, patient-reported quality of life and fatigue, blood-based metabolic markers and body/weight adiposity compared to the current standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: TREParticipants will eat all food within the same self selected 8 hour window daily. |
| Standard care | No intervention | –Current standard care is to eat enough calories and protein to maintain weight and lean mass. |
| Med TRE | Experimental | Behavioral: MedTREParticipants will eat a mediterranean style diet within the same self selected 8 hour window daily. |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 25-99 at time of consent
- ECOG 0 or 1
- Breast cancer to meet histologically confirmed Stage I-III.
- Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL).
- All screening labs to be obtained within 30 days prior to registration.
Key exclusion criteria (21 listed)
- Women with metastatic disease or type 1 or 2 diabetes
- Women with BMI ≥ 40kg/m2 and < 25kg/m2
- Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines.
- Night 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 |
|---|---|---|
| TREAll food eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day. | Behavioural | Time restricted eating |
| MedTREA mediterranean style diet will be eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day. | Behavioural | Med TRE |
Primary outcome
Feasibility 8-h TRE
Time frame: 12 weeks
enrollment rate
7 secondary outcomes
Relative dose intensity
Time frame: 12 weeks
Treatment side effects
Time frame: 12 weeks
EROTC quality of life score
Time frame: 12 weeks
Body weight change
Time frame: 12 weeks
Body composition
Time frame: 12 weeks
Change in glucose
Time frame: 12 weeks
Change in insulin
Time frame: 12 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 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Kelsey Gabel, MS, RD, PhD principal investigator
UIC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE and MedTRE in people with Breast Cancer Female, run by University of Illinois Chicago at 1 site 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 8 inclusion and 21 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 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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, 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?
Feasibility 8-h TRE (time frame: 12 weeks). 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 Oct 2025.