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Can cutting calories boost Radiation's power against breast cancer?

NCT ID NCT04959474

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether adding calorie restriction to a precise, high-dose radiation treatment (SABR) before surgery can shrink breast tumors more than radiation alone. About 80 adults with early-stage breast cancer will be randomly assigned to either standard dietary advice or a calorie-restricted diet during their radiation. The main goal is to see if the combination leads to a greater reduction in tumor cells.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
caloric restriction (dietary intervention) and stereotactic body radiation therapy (SABR)
What this could lead to
If it works, this could point toward a simple dietary change that makes radiation more effective for early-stage breast cancer.
What could go wrong
This is a small, early-phase trial with only 80 participants, so results may not apply to everyone. The calorie restriction may be hard to follow and could cause side effects like fatigue or nutrient deficiencies.

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 80 people

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

Started

Aug 2021

Expected to finish

Nov 2028

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

40 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: * • Patients with pathologically proven DCIS or invasive breast cancer histologies * Willing and able to provide informed consent * Willing and able to comply with study treatments including dietary intervention * Body mass index (BMI) \>= 21 at time of enrollment * Age \>= 40 years at time of consent \* Patients with triple negative breast cancer (TNBC) must be \>= 50 years of age at time of consent * Karnofsky performance status (KPS) score 70 - 100 * Tumor size =\< 3.0 cm * Gross disease within the breast must be unifocal \* Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =\< 3 cm * Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70 * Patient is not being considered for preoperative chemotherapy * Must be English or Spanish speaking Exclusion Criteria: * Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative * Patient has stage IV metastatic disease \* Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met * Breast tumor size is \> 3.0 cm * Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor * Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign * Paget's disease of the nipple * Previous breast radiation on ipsilateral side * Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration * Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician * BMI \< 21 at the time of study enrollment

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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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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