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Diet and exercise program aims to help breast cancer survivors shed pounds

NCT ID NCT04365569

Disease control Sponsor: Case Comprehensive Cancer Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a 6-month personalized nutrition and exercise counseling program for breast cancer survivors who are overweight. The program included meetings with a dietitian and a tailored physical activity plan. Researchers wanted to see if participants could lose 10% of their body weight and stick with healthy habits.

What this could mean

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

Active substance
nutrition and physical activity counseling program
What this could lead to
If successful, this program could offer a practical way for breast cancer survivors to lose weight and improve heart health and quality of life.
What could go wrong
This is a small pilot study with only 78 participants, so results may not apply to everyone. The program requires commitment to counseling and exercise, which may be hard for some to maintain.

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

78 people

The number who actually took part.

Started

Jan 2021

Finished

May 2024

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: * Breast cancer diagnosis (stage 0-III) * Body mass index of 25mg/k2 or greater * Actively being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center * Able and willing to participate in nutrition counseling at Maroone Cancer Center * Able (cleared by participant's primary oncologist) and willing to perform cardiopulmonary exercise testing * Participants must have the ability to understand and the willingness to sign a written informed consent document * Performance status 0 or 1 as per ECOG scale \[see Appendix IV\] Exclusion Criteria: * Body mass index below 25kg/m2 * No prior history of breast cancer * History of metastatic disease * Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Maroone Cancer Center * Unable or unwilling to participate in nutrition counseling at Maroone Cancer Center * Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Participants actively undergoing chemotherapy, immunotherapy or radiation treatment. However, participants currently taking hormonal therapy, such as selective estrogen receptor modulators (SERMS), or aromatase inhibitors, may be included in the study.

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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

Contacts and locations

Locations

  • Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

    Weston, Florida, 33331, United States

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