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Could exercise boost gut health and ease fatigue in breast cancer survivors?

NCT ID NCT04088708

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study looks at how aerobic exercise changes the gut microbiome in breast cancer survivors and whether those changes relate to less fatigue. About 126 women who have finished primary treatment will take part. Researchers will measure gut bacteria from stool samples and track fatigue and inflammation over time.

What this could mean

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

Active substance
Aerobic exercise training
What this could lead to
If successful, this could show that exercise improves fatigue and other symptoms in breast cancer survivors by changing gut bacteria.
What could go wrong
This is an observational study, not a treatment trial. It may not prove cause and effect, and results might not apply to all survivors.

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 126 people

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

Started

Jan 2020

Expected to finish

Aug 2026

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 to 74 years

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: * Women ages 18 to 74 years with a history of breast cancer stage 0, I, II, or III, * ≥ 1-year post-completion of primary treatment for breast cancer (chemotherapy and/or radiation), * Average fatigue over the past week rated as ≥3 on a 1 to 10 Likert scale, cut point chosen because it is a clinically meaningful cutpoint,93 * English speaking, * Physician medical clearance for study participation, * Able to ambulate without assistance, * No antibiotics for the past 90 days, * Willing to avoid taking probiotics for the duration of the study * Peak VO2 \<30 ml/kg/min (note: will measure peak VO2 if the participant meets all other criteria and consents to lab-based screening). Exclusion criteria: * Metastatic or recurrent cancer * Another diagnosis of cancer in the past 5 years (not including skin or cervical cancer in situ), 3) * Unstable angina * New York Heart Association class II, III, or IV congestive heart failure * Uncontrolled asthma * Interstitial lung disease * Current steroid use * Having been told by a physician to only do exercise prescribed by a physician * Dementia or organic brain syndrome * Schizophrenia or active psychosis * Connective tissue or rheumatologic disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, CREST syndrome, polymyositis, dermatomyositis, progressive systemic sclerosis, vasculitis, polymyalgia rheumatic, temporal arteritis) * Anticipate elective surgery during the study period * Anticipate changes in usual medications during the study period * Plan to move residence out of the local area during the study period * Plan to travel out of the local area for \>1 week during study participation * Contraindication to engaging in moderate-to-vigorous intensity aerobic exercise * Currently pregnant or anticipate pregnancy during study participation * Live or work \>50 miles from study site or do not have transportation to study site * BMI \>50 * Anticipate needing antibiotics during the study period

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Fatigue Inflammation Motor Activity

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.