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Can shedding pounds after breast cancer keep it away?

NCT ID NCT03946423

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looks at whether weight-loss surgery (sleeve gastrectomy) combined with lifestyle changes, or lifestyle changes alone, can help women who have had early-stage breast cancer and are obese. The goal is to see if losing weight might lower the chance of the cancer returning. Participants are women who finished breast cancer treatment at least six months ago, have a BMI of 35 or higher, and are disease-free. The study first checks if women are willing to join and stick with the program for a year, with plans for a larger future trial.

What this could mean

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

Active substance
Sleeve gastrectomy (weight-loss surgery) and lifestyle intervention (counseling, diet, exercise)
What this could lead to
If successful, this could show that significant weight loss after breast cancer treatment reduces the risk of cancer coming back.
What could go wrong
This is a small feasibility study, not a large trial. It may not prove that weight loss prevents recurrence, and surgery carries risks like infection or complications.

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.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Feb 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

18 to 67 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: * Diagnosis of breast cancer in the previous 10 years and currently disease free. * Completion of breast cancer treatment (radiation, chemotherapy) at least \> 6 months prior to enrollment * Body mass index (BMI) of ≥ 35 kg/m2, but \< 50 kg/m2. * 18 through 67 years of age at enrollment * Deemed healthy enough to undergo bariatric surgery, if assigned intervention, as determined by a surgeon and documented in the medical record. * Must have insurance coverage with no exclusion for obesity related treatment or management of obesity related surgical complications - in general insurance coverage is available for persons with a BMI ≥ 35 kg/m2. * Anticipated ability to abide by study requirements demonstrated in part by, but not limited to, successful completion of run-in assessments. * Willingness to accept randomization into either interventional group. * Provides voluntary written consent prior to performance of any research related activities. Exclusion Criteria: * Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. * Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. * Cardiac stress test indicating that surgery or lifestyle would not be safe. * 12-lead EKG indicating that surgery would not be safe. * Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy. * History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. * Gastric or duodenal ulcer in the past six months. * History of intra-abdominal sepsis except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment. * Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. * Currently pregnant or nursing, or planning to become pregnant in the next 15 months. * History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years. * Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. * Deemed not an acceptable candidate by a trained psychologist. * Current participation in a conflicting research protocol. * Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. * Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. * Any history of dysphagia.

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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.

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