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 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Castro Valley, California, Verenigde Staten, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Verenigde Staten, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord, California, Verenigde Staten, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Verenigde Staten, 94538
- Valley Medical Oncology
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Martinez, California, Verenigde Staten, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, Verenigde Staten, 94040
- El Camino Hospital Cancer Center
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Oakland, California, Verenigde Staten, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Verenigde Staten, 94602
- Highland General Hospital
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Oakland, California, Verenigde Staten, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Verenigde Staten, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Verenigde Staten, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Verenigde Staten, 94609
- Tom K Lee, Incorporated
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San Pablo, California, Verenigde Staten, 94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek, California, Verenigde Staten, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport, Connecticut, Verenigde Staten, 06606
- St. Vincent's Medical Center
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Delaware
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Lewes, Delaware, Verenigde Staten, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Verenigde Staten, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington D.C., District of Columbia, Verenigde Staten, 20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Dearfield Beach, Florida, Verenigde Staten, 33064-3596
- North Broward Medical Center
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Jupiter, Florida, Verenigde Staten, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, Verenigde Staten, 33140
- CCOP - Mount Sinai Medical Center
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Pensacola, Florida, Verenigde Staten, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee, Florida, Verenigde Staten, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Verenigde Staten, 60631
- Resurrection Medical Center
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Elk Grove Village, Illinois, Verenigde Staten, 60007
- Alexian Brothers Radiation Oncology
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Harvey, Illinois, Verenigde Staten, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline, Illinois, Verenigde Staten, 61265
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Moline, Illinois, Verenigde Staten, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte, Indiana, Verenigde Staten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Verenigde Staten, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Verenigde Staten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Verenigde Staten, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Verenigde Staten, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf, Iowa, Verenigde Staten, 52722
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Kansas
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Chanute, Kansas, Verenigde Staten, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Verenigde Staten, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Verenigde Staten, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Verenigde Staten, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Verenigde Staten, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Verenigde Staten, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Verenigde Staten, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Verenigde Staten, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Verenigde Staten, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Verenigde Staten, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Verenigde Staten, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Verenigde Staten, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Verenigde Staten, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Verenigde Staten, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Verenigde Staten, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Verenigde Staten, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- CCOP - Wichita
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Wichita, Kansas, Verenigde Staten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Verenigde Staten, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Verenigde Staten, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503-9985
- Central Baptist Hospital
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Maine
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York Village, Maine, Verenigde Staten, 03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton MD, Maryland, Verenigde Staten, 21921
- Union Hospital of Cecil County
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Gaithersburg, Maryland, Verenigde Staten, 20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo, Maryland, Verenigde Staten, 20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring, Maryland, Verenigde Staten, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02111
- Tufts Medical Center Cancer Center
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Hyannis, Massachusetts, Verenigde Staten, 02601
- Cape Cod Hospital
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New Jersey
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Elizabeth, New Jersey, Verenigde Staten, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees Township, New Jersey, Verenigde Staten, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island, New York, Verenigde Staten, 10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville, North Carolina, Verenigde Staten, 27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo, North Dakota, Verenigde Staten, 58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus, Ohio, Verenigde Staten, 43210-1240
- Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
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Tennessee
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Cookeville, Tennessee, Verenigde Staten, 38501
- Cookeville Regional Medical Center
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Texas
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Houston, Texas, Verenigde Staten, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, Verenigde Staten, 78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax, Virginia, Verenigde Staten, 22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean, Virginia, Verenigde Staten, 22102
- Kaiser Permanente Tysons Corner Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
Ancillary studies
Receive lymphedema educational materials
Andere namen:
|
|
Experimenteel: 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.
|
Ancillary studies
Receive lymphedema educational materials
Andere namen:
Complete physical therapy-focused intervention
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Tijdsspanne: 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
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18 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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18 months
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Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Studie stoel: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2006
Primaire voltooiing (Werkelijk)
1 november 2015
Studie voltooiing (Werkelijk)
15 juni 2017
Studieregistratiedata
Eerst ingediend
13 september 2006
Eerst ingediend dat voldeed aan de QC-criteria
13 september 2006
Eerst geplaatst (Geschat)
15 september 2006
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
27 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Huidziektes
- Borst ziekten
- Lymfatische ziekten
- Huid- en bindweefselaandoeningen
- Hemische en lymfatische ziekten
- Borstneoplasmata
- Lymfoedeem
- Onderzoekstechnieken
- Therapeutica
- Gezondheidsdiensten
- Gezondheidszorgfaciliteiten personeel en diensten
- Child Health Services
- Community Health Services
- Preventieve gezondheidsdiensten
- Revalidatie
- Methoden
- Vroege interventie, educatief
- Modaliteiten fysiotherapie
Andere studie-ID-nummers
- CALGB-70305
- U10CA037447 (Subsidie/contract van de Amerikaanse NIH)
- CDR0000494652 (Register-ID: NCI Physician Data Query)
- NCI-2009-00488 (Register-ID: NCI Clinical Trial Reporting Program)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Individual Participant Data Set
Bestudeer gegevens/documenten
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .