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 kwietnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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California
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Castro Valley, California, Stany Zjednoczone, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, Stany Zjednoczone, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord, California, Stany Zjednoczone, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, Stany Zjednoczone, 94538
- Valley Medical Oncology
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Martinez, California, Stany Zjednoczone, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, Stany Zjednoczone, 94040
- El Camino Hospital Cancer Center
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Oakland, California, Stany Zjednoczone, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, Stany Zjednoczone, 94602
- Highland General Hospital
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Oakland, California, Stany Zjednoczone, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, Stany Zjednoczone, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, Stany Zjednoczone, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, Stany Zjednoczone, 94609
- Tom K Lee, Incorporated
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San Pablo, California, Stany Zjednoczone, 94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek, California, Stany Zjednoczone, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport, Connecticut, Stany Zjednoczone, 06606
- St. Vincent's Medical Center
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Delaware
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Lewes, Delaware, Stany Zjednoczone, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, Stany Zjednoczone, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington D.C., District of Columbia, Stany Zjednoczone, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington D.C., District of Columbia, Stany Zjednoczone, 20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Dearfield Beach, Florida, Stany Zjednoczone, 33064-3596
- North Broward Medical Center
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Jupiter, Florida, Stany Zjednoczone, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, Stany Zjednoczone, 33140
- CCOP - Mount Sinai Medical Center
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Pensacola, Florida, Stany Zjednoczone, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee, Florida, Stany Zjednoczone, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Stany Zjednoczone, 60631
- Resurrection Medical Center
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Elk Grove Village, Illinois, Stany Zjednoczone, 60007
- Alexian Brothers Radiation Oncology
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Harvey, Illinois, Stany Zjednoczone, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline, Illinois, Stany Zjednoczone, 61265
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Moline, Illinois, Stany Zjednoczone, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte, Indiana, Stany Zjednoczone, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, Stany Zjednoczone, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, Stany Zjednoczone, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, Stany Zjednoczone, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, Stany Zjednoczone, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf, Iowa, Stany Zjednoczone, 52722
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Kansas
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Chanute, Kansas, Stany Zjednoczone, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, Stany Zjednoczone, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, Stany Zjednoczone, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, Stany Zjednoczone, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, Stany Zjednoczone, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, Stany Zjednoczone, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, Stany Zjednoczone, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, Stany Zjednoczone, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, Stany Zjednoczone, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, Stany Zjednoczone, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, Stany Zjednoczone, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, Stany Zjednoczone, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, Stany Zjednoczone, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, Stany Zjednoczone, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, Stany Zjednoczone, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- CCOP - Wichita
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Wichita, Kansas, Stany Zjednoczone, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, Stany Zjednoczone, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, Stany Zjednoczone, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40503-9985
- Central Baptist Hospital
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Maine
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York Village, Maine, Stany Zjednoczone, 03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton MD, Maryland, Stany Zjednoczone, 21921
- Union Hospital of Cecil County
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Gaithersburg, Maryland, Stany Zjednoczone, 20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo, Maryland, Stany Zjednoczone, 20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring, Maryland, Stany Zjednoczone, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Tufts Medical Center Cancer Center
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Hyannis, Massachusetts, Stany Zjednoczone, 02601
- Cape Cod Hospital
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New Jersey
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Elizabeth, New Jersey, Stany Zjednoczone, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees Township, New Jersey, Stany Zjednoczone, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island, New York, Stany Zjednoczone, 10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville, North Carolina, Stany Zjednoczone, 27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus, Ohio, Stany Zjednoczone, 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, Stany Zjednoczone, 38501
- Cookeville Regional Medical Center
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Texas
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Houston, Texas, Stany Zjednoczone, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, Stany Zjednoczone, 78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax, Virginia, Stany Zjednoczone, 22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean, Virginia, Stany Zjednoczone, 22102
- Kaiser Permanente Tysons Corner Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Complete physical therapy-focused intervention
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Krzesło do nauki: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 czerwca 2006
Zakończenie podstawowe (Rzeczywisty)
1 listopada 2015
Ukończenie studiów (Rzeczywisty)
15 czerwca 2017
Daty rejestracji na studia
Pierwszy przesłany
13 września 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 września 2006
Pierwszy wysłany (Szacowany)
15 września 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
18 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 kwietnia 2026
Ostatnia weryfikacja
1 kwietnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby skórne
- Choroby piersi
- Choroby limfatyczne
- Choroby skóry i tkanki łącznej
- Choroby hemowe i limfatyczne
- Nowotwory piersi
- Obrzęk limfatyczny
- Techniki śledcze
- Lecznictwo
- Usługi zdrowotne
- Zakłady opieki zdrowotnej i usługi
- Usługi zdrowia dzieci
- Community Health Services
- Pobieżne usługi zdrowotne
- Rehabilitacja
- Metody
- Wczesna interwencja, edukacja
- Fizjoterapia
Inne numery identyfikacyjne badania
- CALGB-70305
- U10CA037447 (Grant/umowa NIH USA)
- CDR0000494652 (Identyfikator rejestru: NCI Physician Data Query)
- NCI-2009-00488 (Identyfikator rejestru: NCI Clinical Trial Reporting Program)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Individual Participant Data Set
Badanie danych/dokumentów
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .