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LymphedemaNCT00376597

Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection

A study testing quality of life assessment, educational intervention and Physical therapy in people with Lymphedema, run by Alliance for Clinical Trials in Oncology at 76 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Lymphedema
What is being tested?
quality of life assessment, educational intervention and Physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
76 sitesUnited States
Study dates
Jun 2006to 15 Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Kaiser Permanente at Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Study site

    Bettendorf, Iowa, 52722

  • Tufts Medical Center Cancer Center

    Boston, Massachusetts, 02111

  • St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

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

    Columbus, Ohio, 43210-1240

  • Cancer Care Center at John Muir Health - Concord Campus

    Concord, California, 94524-4110

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • North Broward Medical Center

    Dearfield Beach, Florida, 33064-3596

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Trinitas Comprehensive Cancer Center at Trinitas Hospital

    Elizabeth, New Jersey, 07207

  • Alexian Brothers Radiation Oncology

    Elk Grove Village, Illinois, 60007

  • Union Hospital of Cecil County

    Elkton MD, Maryland, 21921

  • Kaiser Permanente Medical Center - Fair Oaks

    Fairfax, Virginia, 22033

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Valley Medical Oncology

    Fremont, California, 94538

  • Kaiser Permanente - Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

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

    Houston, Texas, 77030-4009

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78045

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

    Largo, Maryland, 20774

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Tunnell Cancer Center at Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

  • Cancer Center of Kansas, PA - McPherson

    McPherson, Kansas, 67460

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

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

    Moline, Illinois, 61265

  • Study site

    Moline, Illinois, 61265

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Sacred Heart Cancer Center at Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology-Oncology, PC - South Bend

    South Bend, Indiana, 46601

  • Nalitt Cancer Institute at Staten Island University Hospital

    Staten Island, New York, 10305

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • John Muir/Mt. Diablo Comprehensive Cancer Center

    Walnut Creek, California, 94598

  • Kaiser Permanente at Capitol Hill Medical Center

    Washington D.C., District of Columbia, 20002

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • York Hospital's Oncology Treatment Center

    York Village, Maine, 03909

Other trials in United States

About this study

Official title: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

This randomized phase III trial studies how well education with or without physical therapy intervention works in preventing lymphedema in women with stage I, II, or III breast cancer who are undergoing axillary lymph node dissection (surgery to remove lymph nodes found in the armpit region). Lymphedema is a condition in which extra lymph fluid builds up in tissues and causes swelling in an arm or leg if lymph vessels are blocked, damaged, or removed by surgery. A personalized physical therapy intervention and education materials may be better than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

Read the detailed description

OBJECTIVES:

  1. To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema.

II. To compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.

III. To assess the agreement between patients' self-report of swelling (mild, moderate, and severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference.

IV. To compare the health-related quality of life (Factional Assessment of Cancer Therapy-Breast [FACT-B]+4 score) between the two interventions.

  1. To characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and range of motion.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.

ARM II: Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.

Conditions
Lymphedema
Being tested
quality of life assessment, educational intervention, Physical therapy
Keywords
lymphedema, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Medical subject headings
Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • quality of life assessmentOther

    Ancillary studies

  • educational interventionOther

    Also called intervention, educational

    Receive lymphedema educational materials

  • Physical therapyProcedure or surgery

    Also called physiotherapy

    Complete physical therapy-focused intervention

Study groups in NCT00376597
Study groupRoleWhat they receive
Arm I (lymphedema education)ExperimentalSix weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
Receives: Other: quality of life assessment; Other: educational intervention
Arm II (lymphedema education, physical therapy)ExperimentalDescription Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises.
Receives: Other: quality of life assessment; Other: educational intervention; Procedure: Physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Were Lymphedema-free 18 Months After Randomization

    To test, in a group randomized controlled trial, the efficacy of this program versus education only in reducing the incidence of lymphedema. Reported here is the proportion of patients who are lymphedema-free 18 months after randomization between the two arms

    Measured: 18 months

Secondary outcomes (4)

  1. Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference

    To compare the severity of lymphedema in terms of changes in arm circumference at the site of greatest difference as a continuous variable between the two interventions.

    Measured: 18 months

  2. Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm

    To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement difference between treated side and the contralateral arm at the site of greatest difference. Per protocol, this analysis will include all patients and not be comparing the intervention arm with the control arm.

    Measured: 18 months

  3. Health-related Quality of Life as Assessed by FACT-B +4 Score

    To compare the health-related quality of life (FACT-B+4 score) between the two interventions. The change between baseline and month 18 for the total plus 4 score will be reported here. The total plus 4 score is an average of the physical, social, emotional, functional, FACT-G, and additional concerns sub-scales. Each sub-scale has questions ranging from 1-5. Once the average of all subscales is taken, the total plus 4 score is converted into a score out of 100. 100 being the best, 0 being the worst.

    Measured: 18 months

  4. Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength

    To characterize adherence to lymphedema prevention exercises, lymphedema knowledge and range of motion. The frequency of elastic sleeve use for heavy arm use/exercise/air travel will be reported here. Arm I did not receive a sleeve to wear, thus will not be reported.

    Measured: from baseline up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionNov 2015
  4. Study completion15 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376597
Sponsor's protocol ID
CALGB-70305
Other IDs
CDR0000494652, NCI-2009-00488, U10CA037447
Status last verified
Apr 2026
First submitted
13 Sep 2006
Last updated
18 May 2026
Data monitoring committee
Yes
Individual data sharing
Yes: Individual Participant Data Set

Publications

  • Paskett ED, Le-Rademacher J, Oliveri JM, Liu H, Seisler DK, Sloan JA, Armer JM, Naughton MJ, Hock K, Schwartz M, Unzeitig G, Melnik M, Yee LD, Fleming GF, Taylor JR, Loprinzi C. A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance). Cancer. 2021 Jan 15;127(2):291-299. doi: 10.1002/cncr.33183. Epub 2020 Oct 20.

    PubMed 33079411

  • Naughton MJ, Liu H, Seisler DK, Le-Rademacher J, Armer JM, Oliveri JM, Sloan JA, Hock K, Schwartz M, Unzeitig G, Melnik M, Yee LD, Fleming GF, Taylor JR, Loprinzi C, Paskett ED. Health-related quality of life outcomes for the LEAP study-CALGB 70305 (Alliance): A lymphedema prevention intervention trial for newly diagnosed breast cancer patients. Cancer. 2021 Jan 15;127(2):300-309. doi: 10.1002/cncr.33184. Epub 2020 Oct 20.

    PubMed 33079393

Questions about this trial

What is this clinical trial studying?

A study testing quality of life assessment, educational intervention and Physical therapy in people with Lymphedema, run by Alliance for Clinical Trials in Oncology at 76 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Were Lymphedema-free 18 Months After Randomization (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376597, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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