Breast CancerNCT06106477
Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
A study testing Intermittent Fasting in people with Breast Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intermittent Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2024to 15 Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Progesterone receptor positive or negative patients are allowed.
- Hormone receptor positivity is defined as ER positivity in at least 1% cells by immunohistochemistry (IHC). HER 2-negative breast cancer is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization fluorescence in situ hybridisation (FISH), chromogenic in situ hybridization (CISH), or silver-enhanced in situ hybridization (SISH) test is required.
- Body mass index (BMI) ≥ 25.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
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- Subject must be willing to start the intermittent fasting (IF) intervention within three months of starting adjuvant endocrine therapy (AET), or at the discretion of the treating providers, and within 30 days of study enrollment.
- Subjects who received neoadjuvant or adjuvant chemotherapy must have recovered completely from chemotherapy-related side effects such as nausea/emesis as determined by the treating providers.
- Subjects who received neoadjuvant endocrine therapy are eligible only after completion of their definitive surgery (i.e., when ready to start adjuvant endocrine therapy) and treating provider ensures complete closure and healing of surgical incisions.
- Subjects who had adjuvant systemic chemotherapy within two to four weeks prior to starting the IF intervention are eligible if they have recovered from acute effects of prior therapy to near baseline as determined by the treating physician.
- Subjects on a targeted therapy, such as cyclin-dependent kinase (CDK) 4/6 inhibitor, or selective estrogen receptor degrader (SERD), or other clinical trial participants in the adjuvant setting are eligible at the discretion of the treating physician.
- Subject co-administered with any prescriptions that may cause dizziness, hypoglycemia, or hypotension need to be evaluated and deemed eligible by the treating physician.
- Adequate hepatic, renal function and adequate bone marrow reserve as determined by the treating physician:
- aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × institutional upper limit.
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN), except for subjects with Gilbert's syndrome who may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN.
- alkaline phosphatase (ALP) ≤ 2.5 × institutional upper limit with exception that ALP of < 5 × ULN is acceptable in patients with elevated with ALP due to bone metastases (in the absence of liver metastases).
- Serum creatinine <1.5 × ULN.
- Absolute neutrophil count (ANC) ≥1000/µL.
- Subjects with lymphopenia are eligible at the discretion of the treating provider.
- Hemoglobin (Hb) ≥ 8g/dL. ii. Platelet count ≥ 100,000/µL.
- Premenopausal woman:
- Premenopausal is defined as someone who has had menses at any time in the last 12 months. For premenopausal women who are eligible for this trial, the treating physician may choose to monitor ovarian function with laboratory tests e.g., follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol as clinically indicated to assess their menopausal status.
- Subjects must agree not to conceive throughout the study and must use accepted methods of contraception.
- Women of childbearing potential must have a negative pregnancy test within seven days of registration and or seven to 10 days prior to starting study treatment.
- Subjects who have an atypical sleep-wake schedule or different eating schedules are eligible at the discretion of the study investigators and dietitians as long as they agree to nightly fasting.
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Subject who works late night shifts.
- Subject that was or currently on a fasting diet (e.g., Keto diets), intervention, or an agent (e.g., Ozempic) for the explicit purpose of inducing weight loss in the past one year.
- Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa).
- Presence of diabetes.
- Presence of chronic dizziness or vertigo.
- Presence of endocrine disorders prone to fluctuations in blood sugar (e.g., multiple neuroendocrine disorders, adrenal disorders, chronic hypoglycemia).
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- Poorly controlled neurological disorders as determined by the treating physician (e.g., epilepsy, Parkinson's disease, myasthenia gravis, syncope, pre-syncopal episodes).
- Poorly controlled co-existing cardiac disease as determined by the treating physician, such as chronic hypotension, symptomatic congestive heart failure (New York Heart Association III-IV), unstable angina, arrythmia (e.g., atrial fibrillation, bradycardia, tachycardia).
- History of heavy alcohol use as determined by the treating physician.
- History of liver disease (cirrhosis, active hepatitis) or chronic renal disease.
- Untreated or active infections such as hepatitis, human immunodeficiency virus (HIV), chronic unhealed infections.
- Clinically significant illness or systemic disease as determined by the treating physician.
- Recent hospitalization for a major illness, as determined by the treating physicians, within one month of enrollment.
- Subject who is pregnant or breastfeeding. Subjects who become pregnant while on the study will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sailaja Kamaraju, MD, 414-805-4600, skamaraju@mcw.edu
Sailaja Kamaraju, MD
About this study
This single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).
Read the detailed description
This is a single-arm pilot study (n=20) designed to evaluate whether a six-month intermittent fasting (IF) intervention, defined as a daily recurring fourteen-hour nightly fasting period, is feasible to adhere to and feasible to determine health outcomes in breast cancer patients with a body mass index (BMI) of ≥25 and who are scheduled to start adjuvant endocrine therapy (AET) after definitive therapy.
Subjects with hormone receptor positive, HER2-negative breast cancer will be enrolled into this study. Data on study feasibility, quality of life (QOL) and anthropometric measurements, and biomarkers will be collected and analyzed. After the study is completed, the investigators may also perform a post-hoc analysis on subjects who received adjuvant chemotherapy in combination with AET vs. AET alone.
- Conditions
- Breast Cancer
- Being tested
- Intermittent Fasting
- Keywords
- intermittent fasting, obesity, overweight, breast cancer, hormone receptor positive, HER2-negative, human epidermal growth factor receptor 2-negative, HR-positive, HR+/HER2-, early breast cancer, adjuvant endocrine therapy
- Medical subject headings
- Breast Neoplasms, Intermittent Fasting, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingBehavioural
Participants will be asked to adhere to a six-month intermittent fasting intervention, a daily-recurring dietary plan consisting of:
- An approximately fourteen-hour nightly fasting period that is followed by
- An approximately ten-hour eating period with their last meal of the day occurring between 17:00 (5:00 PM) and 21:00 (9:00 PM).
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Enrolled subjects are expected to start the study intervention after completion of definitive therapy and within three months of starting AET. Receives: Behavioral: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject adherence to the intermittent fasting schedule.
This measure is the number of subjects who adhere to at least 80% of the intermittent fasting schedule (i.e., follow the schedule on average for at least eight out of 10 days) throughout the six-month intervention period.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start19 Jul 2024
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sailaja Kamaraju, Medical College of Wisconsin
- Investigators
- Sailaja Kamaraju, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106477
- Sponsor's protocol ID
- PRO00049422
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2023
- Last updated
- 5 Aug 2026
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Fasting on Biomarkers of Inflammation and Health-Related Quality of Life: A Feasibility Trial for Women With HR+/HER2- Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06106477
- Acronym / sponsor ID
- PRO00049422
- Conditions
- Breast Cancer
- Keywords
- intermittent fasting, obesity, overweight, breast cancer, hormone receptor positive, HER2-negative, human epidermal growth factor receptor 2-negative, HR-positive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 30 Oct 2023 (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 single-arm study is designed to test the hypothesis that a six-month intermittent fasting (IF) intervention is feasible for patients to adhere to and improves health-related quality of life while subjects are on adjuvant endocrine therapy (AET).
Detailed description
This is a single-arm pilot study (n=20) designed to evaluate whether a six-month intermittent fasting (IF) intervention, defined as a daily recurring fourteen-hour nightly fasting period, is feasible to adhere to and feasible to determine health outcomes in breast cancer patients with a body mass index (BMI) of ≥25 and who are scheduled to start adjuvant endocrine therapy (AET) after definitive therapy.
Subjects with hormone receptor positive, HER2-negative breast cancer will be enrolled into this study. Data on study feasibility, quality of life (QOL) and anthropometric measurements, and biomarkers will be collected and analyzed. After the study is completed, the investigators may also perform a post-hoc analysis on subjects who received adjuvant chemotherapy in combination with AET vs. AET alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | Behavioral: Intermittent FastingEnrolled subjects are expected to start the study intervention after completion of definitive therapy and within three months of starting AET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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).
- Body mass index (BMI) ≥ 25.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Subject must be willing to start the intermittent fasting (IF) intervention within three months of starting adjuvant endocrine therapy (AET), or at the discretion of the treating providers, and within 30 days of study enrollment.
Key exclusion criteria (14 listed)
- Subject who works late night shifts.
- Subject that was or currently on a fasting diet (e.g., Keto diets), intervention, or an agent (e.g., Ozempic) for the explicit purpose of inducing weight loss in the past one year.
- Subject with a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa).
- Presence of diabetes.
- Presence of chronic dizziness or vertigo.
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 |
|---|---|---|
| Intermittent FastingParticipants will be asked to adhere to a six-month intermittent fasting intervention, a daily-recurring dietary plan consisting of: * An approximately fourteen-hour nightly fasting period that is followed by * An approximately ten-hour eating period with their last meal of the day occurring between 17:00 (5:00 PM) and 21:00 (9:00 PM). | Behavioural | Intermittent Fasting |
Primary outcome
Subject adherence to the intermittent fasting schedule.
Time frame: Six months
This measure is the number of subjects who adhere to at least 80% of the intermittent fasting schedule (i.e., follow the schedule on average for at least eight out of 10 days) throughout the six-month intervention period.
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 5 Aug 2026.
- 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.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Sailaja Kamaraju, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with Breast Cancer, run by Medical College of Wisconsin 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 26 inclusion and 14 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 5 Aug 2026. 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 Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject adherence to the intermittent fasting schedule. (time frame: Six months). 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 5 Aug 2026.