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Diet and exercise may boost chemotherapy completion in breast cancer patients

NCT ID NCT03314688

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether a program of motivational counseling to follow diet and exercise guidelines helps women newly diagnosed with breast cancer complete their chemotherapy and hormone therapy as planned. About 173 women scheduled for chemotherapy will be randomly assigned to receive the counseling or standard care. The goal is to see if lifestyle support can improve treatment adherence and body composition.

What this could mean

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

Active substance
Motivational counseling to follow established dietary and exercise guidelines
What this could lead to
If successful, this approach could improve how well women complete their prescribed breast cancer treatments, potentially leading to better outcomes.
What could go wrong
This is a relatively small behavioral study, and the benefits may be modest or not apply to all patients. Adherence was measured partly through self-report, which can be unreliable.

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

173 people

The number who actually took part.

Started

Jan 2018

Finished

Jun 2023

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: * Diagnosed with Stage I-III breast cancer * Scheduled to receive neoadjuvant or adjuvant chemotherapy * Physically able to walk * Able to complete forms, understand instructions and read intervention book in English * Agrees to be randomly assigned to either intervention or usual care group Exclusion Criteria: * Women who have completed their 2nd chemotherapy * Women already practicing dietary or physical activity guidelines * Are pregnant or intending to become pregnant in the next year * Recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \< 40% * Presence of dementia or major psychiatric disease * Non-English speaking

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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 neoplasms

Contacts and locations

Locations

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02215, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

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