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Can a 4-Week mediterranean diet boost breast cancer surgery recovery?

NCT ID NCT07638150

Knowledge-focused Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 4 times

Summary

This pilot study will test whether a 4-week Mediterranean diet program is practical and acceptable for women newly diagnosed with breast cancer before they have surgery. Twenty post-menopausal women with stage I-III breast cancer will receive all their meals and snacks. The main goal is to see if participants stick with the diet and find it satisfying, while also looking at changes in body composition, inflammation, and recovery.

What this could mean

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

Active substance
Mediterranean diet meals
What this could lead to
If successful, this could show that a short-term Mediterranean diet before surgery is practical and may help improve recovery and health outcomes for breast cancer patients.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply to all patients. It only tests feasibility, not whether the diet actually improves health or recovery.

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 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

Female participants only

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: * Newly diagnosed stage I-III breast cancer. * Treatment-naïve; no neoadjuvant therapy planned. * Surgery scheduled at Moffitt in 1-2 months. * Post-menopausal. * BMI 28-35 kg/m². * NCI Fruit \& Vegetable Screener \<5 servings/day. * Willing to consume only study-provided meals. Exclusion Criteria: * Stage IV/metastatic disease. * Prior cancer. * Surgery scheduled sooner than 4-5 weeks. * NCI FVS ≥5 servings/day. * Celiac disease, severe food allergies, severe renal disease, uncontrolled diabetes, or medically prescribed incompatible diets.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

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

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

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