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Fasting during chemo: a new way to boost treatment?

NCT ID NCT05327608

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asplundh Cancer Pavilion

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Jefferson Cherry Hill Hospital

    RECRUITING

    Cherry Hill, New Jersey, 08002, United States

  • Jefferson Torresdale Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19114, United States

  • Sidney Kimmel Cancer Center Washington Township, , NJ USA

    RECRUITING

    Sewell, New Jersey, 08080, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

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