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Simple therapy may stop breast Cancer's swelling side effect

NCT ID NCT00376597

Prevention Sponsor: Alliance for Clinical Trials in Oncology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether adding physical therapy to educational materials could prevent lymphedema (arm swelling) in women treated for breast cancer. Over 1,000 women who had lymph nodes removed were randomly assigned to receive either education alone or education plus a personalized physical therapy program. The goal was to see if the therapy group had fewer cases of lymphedema 18 months later.

What this could mean

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

Active substance
physical therapy and educational intervention
What this could lead to
If successful, this could provide a proven way to prevent lymphedema in breast cancer survivors, reducing swelling and improving quality of life.
What could go wrong
The trial is completed, but results may not apply to all patients. Physical therapy requires time and effort, and some women may still develop lymphedema despite the intervention.

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.

Started

Jun 2006

Finished

Jun 2017

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.

Eligibility Criteria: * Newly diagnosed with stage I-III cancer of the female breast * No prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer \* Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis; patients with basal cell and squamous cell cancer of the skin are eligible * Neoadjuvant therapy * Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy * Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy * Patients receiving no neoadjuvant therapy are eligible * May be enrolled on other treatment trials; however, patients enrolled on surgery trials where only one treatment arm is full axillary node dissection are not eligible; NOTE: Patients enrolled on American College of Surgeons Oncology Group (ACOSOG)-Z1071 are eligible to participate in this study; patients concurrently enrolled on this study and ACOSOG-Z1071, may not also be enrolled on the ACOSOG-Z1071 lymphedema sub-study * No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years * No diagnosed lymphedema * In order to be properly fitted for the elastic sleeve, eligible patients must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of the six sleeve sizes * Not currently homebound or dependent upon a walker or wheelchair for mobility * Able to participate in a mild exercise program * Willing to return to the study site for the duration of the study (18 months) * Sentinel (SND) or full axillary node dissection (AND) (no minimum number of nodes required) * Patients with double mastectomy, axillary node dissection and/or radiation on both arms are ineligible; patients who undergo these treatments (i.e., surgery and/or radiation) on the contralateral arm after registration to Step 2 are still eligible to remain in the study; however, it should be documented appropriately on form C-1628 at the conclusion of study participation

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm lymphedema prevention target

As listed by the trial registrant

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

Lymphedema

Contacts and locations

Locations

  • Study site

    Moline, Illinois, 61265, United States

  • Study site

    Bettendorf, Iowa, 52722, United States

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007, United States

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609, United States

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240, United States

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208, United States

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609, United States

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609, United States

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713, United States

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122, United States

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601, United States

  • CCOP - Wichita

    Wichita, Kansas, 67214, United States

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110, United States

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701, United States

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720, United States

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801, United States

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042, United States

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068, United States

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901, United States

  • Cancer Center of Kansas, PA - McPherson

    McPherson, Kansas, 67460, United States

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208, United States

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114, United States

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357, United States

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124, United States

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401, United States

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152, United States

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214, United States

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156, United States

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301, United States

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601, United States

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350, United States

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985, United States

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156, United States

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501, United States

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78045, United States

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806, United States

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546, United States

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040, United States

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458, United States

  • Highland General Hospital

    Oakland, California, 94602, United States

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910, United States

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • John Muir/Mt. Diablo Comprehensive Cancer Center

    Walnut Creek, California, 94598, United States

  • Kaiser Permanente - Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879, United States

  • Kaiser Permanente Medical Center - Fair Oaks

    Fairfax, Virginia, 22033, United States

  • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility

    Largo, Maryland, 20774, United States

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102, United States

  • Kaiser Permanente at Capitol Hill Medical Center

    Washington D.C., District of Columbia, 20002, United States

  • Kaiser Permanente at Woodlawn Medical Center

    Baltimore, Maryland, 21244, United States

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609, United States

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044, United States

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834, United States

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009, United States

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601, United States

  • Michiana Hematology-Oncology, PC - South Bend

    South Bend, Indiana, 46601, United States

  • Nalitt Cancer Institute at Staten Island University Hospital

    Staten Island, New York, 10305, United States

  • North Broward Medical Center

    Dearfield Beach, Florida, 33064-3596, United States

  • Resurrection Medical Center

    Chicago, Illinois, 60631, United States

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504, United States

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470, United States

  • St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • Tom K Lee, Incorporated

    Oakland, California, 94609, United States

  • Trinitas Comprehensive Cancer Center at Trinitas Hospital

    Elizabeth, New Jersey, 07207, United States

  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

    Moline, Illinois, 61265, United States

  • Tufts Medical Center Cancer Center

    Boston, Massachusetts, 02111, United States

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958, United States

  • Union Hospital of Cecil County

    Elkton MD, Maryland, 21921, United States

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470, United States

  • Valley Medical Oncology

    Fremont, California, 94538, United States

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546, United States

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214, United States

  • York Hospital's Oncology Treatment Center

    York Village, Maine, 03909, United States

More trials for these conditions

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