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 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
|
|
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
Outros nomes:
Complete physical therapy-focused intervention
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Prazo: 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
|
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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
Prazo: 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
|
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Health-related Quality of Life as Assessed by FACT-B +4 Score
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2006
Conclusão Primária (Real)
1 de novembro de 2015
Conclusão do estudo (Real)
15 de junho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
13 de setembro de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de setembro de 2006
Primeira postagem (Estimado)
15 de setembro de 2006
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças de pele
- Doenças da mama
- Doenças Linfáticas
- Doenças da Pele e do Tecido Conjuntivo
- Doenças hemic e linfáticas
- Neoplasias da Mama
- Linfedema
- Técnicas de investigação
- Terapêutica
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Serviços de Saúde Infantil
- Serviços de Saúde Comunitária
- Serviços de Saúde Preventiva
- Reabilitação
- Métodos
- Intervenção precoce, educacional
- Modalidades de fisioterapia
Outros números de identificação do estudo
- CALGB-70305
- U10CA037447 (Concessão/Contrato do NIH dos EUA)
- CDR0000494652 (Identificador de registro: NCI Physician Data Query)
- NCI-2009-00488 (Identificador de registro: NCI Clinical Trial Reporting Program)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Individual Participant Data Set
Dados/documentos do estudo
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .