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 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Castro Valley, California, Estados Unidos, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Estados Unidos, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord, California, Estados Unidos, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Estados Unidos, 94538
- Valley Medical Oncology
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Martinez, California, Estados Unidos, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, Estados Unidos, 94040
- El Camino Hospital Cancer Center
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Oakland, California, Estados Unidos, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Estados Unidos, 94602
- Highland General Hospital
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Oakland, California, Estados Unidos, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Estados Unidos, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Estados Unidos, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Estados Unidos, 94609
- Tom K Lee, Incorporated
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San Pablo, California, Estados Unidos, 94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek, California, Estados Unidos, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport, Connecticut, Estados Unidos, 06606
- St. Vincent's Medical Center
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Delaware
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Lewes, Delaware, Estados Unidos, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Estados Unidos, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington D.C., District of Columbia, Estados Unidos, 20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Dearfield Beach, Florida, Estados Unidos, 33064-3596
- North Broward Medical Center
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Jupiter, Florida, Estados Unidos, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, Estados Unidos, 33140
- CCOP - Mount Sinai Medical Center
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Pensacola, Florida, Estados Unidos, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee, Florida, Estados Unidos, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, Estados Unidos, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Estados Unidos, 60631
- Resurrection Medical Center
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Elk Grove Village, Illinois, Estados Unidos, 60007
- Alexian Brothers Radiation Oncology
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Harvey, Illinois, Estados Unidos, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline, Illinois, Estados Unidos, 61265
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Moline, Illinois, Estados Unidos, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte, Indiana, Estados Unidos, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Estados Unidos, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Estados Unidos, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Estados Unidos, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Estados Unidos, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf, Iowa, Estados Unidos, 52722
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Kansas
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Chanute, Kansas, Estados Unidos, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Estados Unidos, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Estados Unidos, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Estados Unidos, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Estados Unidos, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Estados Unidos, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Estados Unidos, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Estados Unidos, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Estados Unidos, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Estados Unidos, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Estados Unidos, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Estados Unidos, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Estados Unidos, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Estados Unidos, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Estados Unidos, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Estados Unidos, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- CCOP - Wichita
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Wichita, Kansas, Estados Unidos, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Estados Unidos, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Estados Unidos, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503-9985
- Central Baptist Hospital
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Maine
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York Village, Maine, Estados Unidos, 03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton MD, Maryland, Estados Unidos, 21921
- Union Hospital of Cecil County
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Gaithersburg, Maryland, Estados Unidos, 20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo, Maryland, Estados Unidos, 20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring, Maryland, Estados Unidos, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02111
- Tufts Medical Center Cancer Center
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Hyannis, Massachusetts, Estados Unidos, 02601
- Cape Cod Hospital
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New Jersey
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Elizabeth, New Jersey, Estados Unidos, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees Township, New Jersey, Estados Unidos, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island, New York, Estados Unidos, 10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville, North Carolina, Estados Unidos, 27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus, Ohio, Estados Unidos, 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, Estados Unidos, 38501
- Cookeville Regional Medical Center
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Texas
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Houston, Texas, Estados Unidos, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, Estados Unidos, 78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax, Virginia, Estados Unidos, 22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean, Virginia, Estados Unidos, 22102
- Kaiser Permanente Tysons Corner Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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
Otros nombres:
|
|
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
Otros nombres:
Complete physical therapy-focused intervention
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Periodo de tiempo: 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.
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18 months
|
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Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm
Periodo de tiempo: 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.
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18 months
|
|
Health-related Quality of Life as Assessed by FACT-B +4 Score
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2006
Finalización primaria (Actual)
1 de noviembre de 2015
Finalización del estudio (Actual)
15 de junio de 2017
Fechas de registro del estudio
Enviado por primera vez
13 de septiembre de 2006
Primero enviado que cumplió con los criterios de control de calidad
13 de septiembre de 2006
Publicado por primera vez (Estimado)
15 de septiembre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades linfáticas
- Enfermedades de la piel y del tejido conectivo
- Enfermedades hemic y linfáticas
- Neoplasias de mama
- Linfedema
- Técnicas de investigación
- Terapéutica
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud infantil
- Servicios de salud comunitarios
- Servicios de salud preventivos
- Rehabilitación
- Métodos
- Intervención temprana, educativa
- Modalidades de fisioterapia
Otros números de identificación del estudio
- CALGB-70305
- U10CA037447 (Subvención/contrato del NIH de EE. UU.)
- CDR0000494652 (Identificador de registro: NCI Physician Data Query)
- NCI-2009-00488 (Identificador de registro: NCI Clinical Trial Reporting Program)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual Participant Data Set
Datos del estudio/Documentos
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .