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 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
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Castro Valley, California, Vereinigte Staaten, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Vereinigte Staaten, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord, California, Vereinigte Staaten, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Vereinigte Staaten, 94538
- Valley Medical Oncology
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Martinez, California, Vereinigte Staaten, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, Vereinigte Staaten, 94040
- El Camino Hospital Cancer Center
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Oakland, California, Vereinigte Staaten, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Vereinigte Staaten, 94602
- Highland General Hospital
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Oakland, California, Vereinigte Staaten, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Vereinigte Staaten, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Vereinigte Staaten, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Vereinigte Staaten, 94609
- Tom K Lee, Incorporated
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San Pablo, California, Vereinigte Staaten, 94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek, California, Vereinigte Staaten, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport, Connecticut, Vereinigte Staaten, 06606
- St. Vincent's Medical Center
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Delaware
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Lewes, Delaware, Vereinigte Staaten, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Vereinigte Staaten, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington D.C., District of Columbia, Vereinigte Staaten, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington D.C., District of Columbia, Vereinigte Staaten, 20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Dearfield Beach, Florida, Vereinigte Staaten, 33064-3596
- North Broward Medical Center
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Jupiter, Florida, Vereinigte Staaten, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, Vereinigte Staaten, 33140
- CCOP - Mount Sinai Medical Center
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Pensacola, Florida, Vereinigte Staaten, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee, Florida, Vereinigte Staaten, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Vereinigte Staaten, 60631
- Resurrection Medical Center
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Elk Grove Village, Illinois, Vereinigte Staaten, 60007
- Alexian Brothers Radiation Oncology
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Harvey, Illinois, Vereinigte Staaten, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline, Illinois, Vereinigte Staaten, 61265
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Moline, Illinois, Vereinigte Staaten, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte, Indiana, Vereinigte Staaten, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Vereinigte Staaten, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Vereinigte Staaten, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Vereinigte Staaten, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Vereinigte Staaten, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf, Iowa, Vereinigte Staaten, 52722
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Kansas
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Chanute, Kansas, Vereinigte Staaten, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Vereinigte Staaten, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Vereinigte Staaten, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Vereinigte Staaten, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Vereinigte Staaten, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Vereinigte Staaten, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Vereinigte Staaten, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Vereinigte Staaten, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Vereinigte Staaten, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Vereinigte Staaten, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Vereinigte Staaten, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Vereinigte Staaten, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Vereinigte Staaten, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Vereinigte Staaten, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Vereinigte Staaten, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Vereinigte Staaten, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Vereinigte Staaten, 67214
- CCOP - Wichita
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Wichita, Kansas, Vereinigte Staaten, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Vereinigte Staaten, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Vereinigte Staaten, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40503-9985
- Central Baptist Hospital
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Maine
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York Village, Maine, Vereinigte Staaten, 03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton MD, Maryland, Vereinigte Staaten, 21921
- Union Hospital of Cecil County
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Gaithersburg, Maryland, Vereinigte Staaten, 20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo, Maryland, Vereinigte Staaten, 20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring, Maryland, Vereinigte Staaten, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02111
- Tufts Medical Center Cancer Center
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Hyannis, Massachusetts, Vereinigte Staaten, 02601
- Cape Cod Hospital
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New Jersey
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Elizabeth, New Jersey, Vereinigte Staaten, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees Township, New Jersey, Vereinigte Staaten, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island, New York, Vereinigte Staaten, 10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville, North Carolina, Vereinigte Staaten, 27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo, North Dakota, Vereinigte Staaten, 58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 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, Vereinigte Staaten, 38501
- Cookeville Regional Medical Center
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Texas
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Houston, Texas, Vereinigte Staaten, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, Vereinigte Staaten, 78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax, Virginia, Vereinigte Staaten, 22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean, Virginia, Vereinigte Staaten, 22102
- Kaiser Permanente Tysons Corner Medical Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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:
|
|
Experimental: 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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Studienstuhl: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juni 2006
Primärer Abschluss (Tatsächlich)
1. November 2015
Studienabschluss (Tatsächlich)
15. Juni 2017
Studienanmeldedaten
Zuerst eingereicht
13. September 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. September 2006
Zuerst gepostet (Geschätzt)
15. September 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach Standort
- Neubildungen
- Hautkrankheiten
- Brusterkrankungen
- Lymphatische Erkrankungen
- Haut- und Bindegewebserkrankungen
- Hämische und lymphatische Krankheiten
- Neoplasien der Brust
- Lymphödem
- Untersuchungstechniken
- Therapeutika
- Gesundheitsdienste
- Belegschaft und Dienstleistungen für Gesundheitseinrichtungen
- Kindergesundheitsdienste
- Community Health Services
- Präventive Gesundheitsdienste
- Rehabilitation
- Methoden
- Frühintervention, Bildung
- Physiotherapiemodalitäten
Andere Studien-ID-Nummern
- CALGB-70305
- U10CA037447 (US NIH Stipendium/Vertrag)
- CDR0000494652 (Registrierungskennung: NCI Physician Data Query)
- NCI-2009-00488 (Registrierungskennung: NCI Clinical Trial Reporting Program)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Individual Participant Data Set
Studiendaten/Dokumente
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .