Can cutting calories boost Radiation's power against breast cancer?
NCT ID NCT04959474
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 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: * • 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anatomic stage 0 breast cancer ajcc V8 are added.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Blood test aims to catch Cancer's return earlier
- Could skipping a lymph node check spare women from unneeded surgery?
- Could shedding pounds after breast cancer keep the disease away?
- Can a Tumor-Blood-Vessel blocker boost hormone therapy for advanced breast cancer?
- 3D imaging could help surgeons remove all breast cancer in one go
- Can freezing breast tumors replace the scalpel?