Fasting during chemo: a new way to boost treatment?
NCT ID NCT05327608
First seen Aug 11, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This trial tests whether time-restricted eating (TRE) — a 16:8 fasting schedule — is feasible for patients with HER2-negative breast cancer undergoing neoadjuvant chemotherapy. Participants will follow TRE for 16 weeks while receiving chemo, and researchers will measure how many patients can stick to the fasting plan at least 70% of the time. The study also looks at whether TRE affects body weight, waist size, and the rate of complete tumor response to chemotherapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Time-restricted eating (intermittent fasting) — a 16:8 schedule of 16 hours fasting and 8 hours eating
- What this could lead to
- If time-restricted eating is feasible and beneficial, it could become a supportive strategy to help breast cancer patients tolerate chemotherapy and potentially improve treatment response.
- What could go wrong
- This is a small phase 2 trial, so results may not be conclusive. Adherence to fasting can be challenging, and the study does not yet prove that fasting improves cancer outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
INCLUSION CRITERIA: * Patient must be \>= 18 years of age at time of consent and must be able to understand and provide informed consent * BMI 25-40 at time of enrollment * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma \* Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy * Patients must have clinical stage I-III (utilizing tumor, node, metastasis \[TNM\] criterion) at diagnosis * Clinical T size must be \>= 1.5 cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved * Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy * Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician * Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks * Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention * Patient must have a personal email address, an internet-capable device, and the ability/ willingness to read and reply to email every day for the duration of the study EXCLUSION CRITERIA: * Clinical T4 and/or N3 disease, including inflammatory breast cancer * Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy * Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention * Patients with type 1 diabetes, or type 2 diabetes treated with insulin * Patients with a history of eating disorder * Patients who work on a rotating shift schedule * Patients must not have impaired decision-making capacity * Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool * Patients that are \> 2 weeks into starting neoadjuvant chemotherapy regimen
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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Asplundh Cancer Pavilion
RECRUITINGWillow Grove, Pennsylvania, 19090, United States
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Jefferson Cherry Hill Hospital
RECRUITINGCherry Hill, New Jersey, 08002, United States
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Jefferson Torresdale Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19114, United States
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Sidney Kimmel Cancer Center Washington Township, , NJ USA
RECRUITINGSewell, New Jersey, 08080, United States
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Thomas Jefferson University Hospital
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
Contact Email: •••••@•••••
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