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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

27. april 2026 oppdatert av: Alliance for Clinical Trials in Oncology

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

I. 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.

V. 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.

Studietype

Intervensjonell

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Castro Valley, California, Forente stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forente stater, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Concord, California, Forente stater, 94524-4110
        • Cancer Care Center at John Muir Health - Concord Campus
      • Fremont, California, Forente stater, 94538
        • Valley Medical Oncology
      • Martinez, California, Forente stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, Forente stater, 94040
        • El Camino Hospital Cancer Center
      • Oakland, California, Forente stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forente stater, 94602
        • Highland General Hospital
      • Oakland, California, Forente stater, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, Forente stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, Forente stater, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, Forente stater, 94609
        • Tom K Lee, Incorporated
      • San Pablo, California, Forente stater, 94806
        • Doctors Medical Center - San Pablo Campus
      • Walnut Creek, California, Forente stater, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
    • Connecticut
      • Bridgeport, Connecticut, Forente stater, 06606
        • St. Vincent's Medical Center
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forente stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington D.C., District of Columbia, Forente stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Washington D.C., District of Columbia, Forente stater, 20002
        • Kaiser Permanente at Capitol Hill Medical Center
    • Florida
      • Dearfield Beach, Florida, Forente stater, 33064-3596
        • North Broward Medical Center
      • Jupiter, Florida, Forente stater, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, Forente stater, 33140
        • CCOP - Mount Sinai Medical Center
      • Pensacola, Florida, Forente stater, 32504
        • Sacred Heart Cancer Center at Sacred Heart Hospital
      • Tallahassee, Florida, Forente stater, 32308
        • Tallahassee Memorial Hospital
    • Illinois
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forente stater, 60631
        • Resurrection Medical Center
      • Elk Grove Village, Illinois, Forente stater, 60007
        • Alexian Brothers Radiation Oncology
      • Harvey, Illinois, Forente stater, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Moline, Illinois, Forente stater, 61265
      • Moline, Illinois, Forente stater, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
    • Indiana
      • La Porte, Indiana, Forente stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, Forente stater, 46545-1470
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, Forente stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forente stater, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Forente stater, 46601
        • Michiana Hematology-Oncology, PC - South Bend
    • Iowa
      • Bettendorf, Iowa, Forente stater, 52722
    • Kansas
      • Chanute, Kansas, Forente stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forente stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forente stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forente stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forente stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forente stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forente stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forente stater, 67901
        • Cancer Center of Kansas, PA - Liberal
      • McPherson, Kansas, Forente stater, 67460
        • Cancer Center of Kansas, PA - McPherson
      • Newton, Kansas, Forente stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Forente stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, Forente stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forente stater, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forente stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forente stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forente stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forente stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forente stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forente stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forente stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503-9985
        • Central Baptist Hospital
    • Maine
      • York Village, Maine, Forente stater, 03909
        • York Hospital's Oncology Treatment Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21244
        • Kaiser Permanente at Woodlawn Medical Center
      • Elkton MD, Maryland, Forente stater, 21921
        • Union Hospital of Cecil County
      • Gaithersburg, Maryland, Forente stater, 20879
        • Kaiser Permanente - Gaithersburg Medical Center
      • Largo, Maryland, Forente stater, 20774
        • Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
      • Silver Spring, Maryland, Forente stater, 20910
        • Holy Cross Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts Medical Center Cancer Center
      • Hyannis, Massachusetts, Forente stater, 02601
        • Cape Cod Hospital
    • New Jersey
      • Elizabeth, New Jersey, Forente stater, 07207
        • Trinitas Comprehensive Cancer Center at Trinitas Hospital
      • Voorhees Township, New Jersey, Forente stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Staten Island, New York, Forente stater, 10305
        • Nalitt Cancer Institute at Staten Island University Hospital
    • North Carolina
      • Greenville, North Carolina, Forente stater, 27834
        • Leo W. Jenkins Cancer Center at ECU Medical School
    • North Dakota
      • Fargo, North Dakota, Forente stater, 58122
        • CCOP - MeritCare Hospital
    • Ohio
      • Columbus, Ohio, Forente stater, 43210-1240
        • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
    • Tennessee
      • Cookeville, Tennessee, Forente stater, 38501
        • Cookeville Regional Medical Center
    • Texas
      • Houston, Texas, Forente stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Laredo, Texas, Forente stater, 78045
        • Doctor's Hospital of Laredo
    • Virginia
      • Fairfax, Virginia, Forente stater, 22033
        • Kaiser Permanente Medical Center - Fair Oaks
      • McLean, Virginia, Forente stater, 22102
        • Kaiser Permanente Tysons Corner Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I (lymphedema education)
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.
Annen: quality of life assessment
Ancillary studies
Annen: educational intervention
Receive lymphedema educational materials
Andre navn:
  • intervensjon, pedagogisk
Eksperimentell: Arm II (lymphedema education, physical therapy)
Description 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.
Annen: quality of life assessment
Ancillary studies
Annen: educational intervention
Receive lymphedema educational materials
Andre navn:
  • intervensjon, pedagogisk
Fremgangsmåte: Physical therapy
Complete physical therapy-focused intervention
Andre navn:
  • fysioterapi

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Tidsramme: 18 months
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
18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Tidsramme: 18 months
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.
18 months
Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm
Tidsramme: 18 months
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.
18 months
Health-related Quality of Life as Assessed by FACT-B +4 Score
Tidsramme: 18 months
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.
18 months
Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength
Tidsramme: from baseline up to 18 months
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.
from baseline up to 18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2006

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

15. juni 2017

Datoer for studieregistrering

Først innsendt

13. september 2006

Først innsendt som oppfylte QC-kriteriene

13. september 2006

Først lagt ut (Antatt)

15. september 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CALGB-70305
  • U10CA037447 (U.S. NIH-stipend/kontrakt)
  • CDR0000494652 (Registeridentifikator: NCI Physician Data Query)
  • NCI-2009-00488 (Registeridentifikator: NCI Clinical Trial Reporting Program)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Individual Participant Data Set

Studiedata/dokumenter

  1. Datasett for individuell deltaker

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere