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
2026년 4월 27일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
중재적
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Castro Valley, California, 미국, 94546
- East Bay Radiation Oncology Center
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Castro Valley, California, 미국, 94546
- Valley Medical Oncology Consultants - Castro Valley
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Concord, California, 미국, 94524-4110
- Cancer Care Center at John Muir Health - Concord Campus
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Fremont, California, 미국, 94538
- Valley Medical Oncology
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Martinez, California, 미국, 94553-3156
- Contra Costa Regional Medical Center
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Mountain View, California, 미국, 94040
- El Camino Hospital Cancer Center
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Oakland, California, 미국, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Oakland, California, 미국, 94602
- Highland General Hospital
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Oakland, California, 미국, 94609
- Larry G Strieff MD Medical Corporation
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Oakland, California, 미국, 94609
- CCOP - Bay Area Tumor Institute
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Oakland, California, 미국, 94609
- Bay Area Breast Surgeons, Incorporated
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Oakland, California, 미국, 94609
- Tom K Lee, Incorporated
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San Pablo, California, 미국, 94806
- Doctors Medical Center - San Pablo Campus
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Walnut Creek, California, 미국, 94598
- John Muir/Mt. Diablo Comprehensive Cancer Center
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Connecticut
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Bridgeport, Connecticut, 미국, 06606
- St. Vincent's Medical Center
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Delaware
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Lewes, Delaware, 미국, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, 미국, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington D.C., District of Columbia, 미국, 20007
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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Washington D.C., District of Columbia, 미국, 20002
- Kaiser Permanente at Capitol Hill Medical Center
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Florida
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Dearfield Beach, Florida, 미국, 33064-3596
- North Broward Medical Center
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Jupiter, Florida, 미국, 33458
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
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Miami Beach, Florida, 미국, 33140
- CCOP - Mount Sinai Medical Center
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Pensacola, Florida, 미국, 32504
- Sacred Heart Cancer Center at Sacred Heart Hospital
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Tallahassee, Florida, 미국, 32308
- Tallahassee Memorial Hospital
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Illinois
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Chicago, Illinois, 미국, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60631
- Resurrection Medical Center
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Elk Grove Village, Illinois, 미국, 60007
- Alexian Brothers Radiation Oncology
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Harvey, Illinois, 미국, 60426
- Ingalls Cancer Care Center at Ingalls Memorial Hospital
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Moline, Illinois, 미국, 61265
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Moline, Illinois, 미국, 61265
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
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Indiana
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La Porte, Indiana, 미국, 46350
- Center for Cancer Therapy at LaPorte Hospital and Health Services
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Mishawaka, Indiana, 미국, 46545-1470
- Saint Joseph Regional Medical Center
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South Bend, Indiana, 미국, 46601
- Memorial Hospital of South Bend
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South Bend, Indiana, 미국, 46601
- CCOP - Northern Indiana CR Consortium
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South Bend, Indiana, 미국, 46601
- Michiana Hematology-Oncology, PC - South Bend
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Iowa
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Bettendorf, Iowa, 미국, 52722
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Kansas
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Chanute, Kansas, 미국, 66720
- Cancer Center of Kansas, PA - Chanute
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Dodge City, Kansas, 미국, 67801
- Cancer Center of Kansas, PA - Dodge City
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El Dorado, Kansas, 미국, 67042
- Cancer Center of Kansas, PA - El Dorado
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Fort Scott, Kansas, 미국, 66701
- Cancer Center of Kansas - Fort Scott
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Independence, Kansas, 미국, 67301
- Cancer Center of Kansas-Independence
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Kingman, Kansas, 미국, 67068
- Cancer Center of Kansas, PA - Kingman
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Lawrence, Kansas, 미국, 66044
- Lawrence Memorial Hospital
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Liberal, Kansas, 미국, 67901
- Cancer Center of Kansas, PA - Liberal
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McPherson, Kansas, 미국, 67460
- Cancer Center of Kansas, PA - McPherson
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Newton, Kansas, 미국, 67114
- Cancer Center of Kansas, PA - Newton
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Parsons, Kansas, 미국, 67357
- Cancer Center of Kansas, PA - Parsons
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Pratt, Kansas, 미국, 67124
- Cancer Center of Kansas, PA - Pratt
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Salina, Kansas, 미국, 67401
- Cancer Center of Kansas, PA - Salina
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Wellington, Kansas, 미국, 67152
- Cancer Center of Kansas, PA - Wellington
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Wichita, Kansas, 미국, 67208
- Cancer Center of Kansas, PA - Medical Arts Tower
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Wichita, Kansas, 미국, 67214
- Cancer Center of Kansas, PA - Wichita
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Wichita, Kansas, 미국, 67214
- CCOP - Wichita
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Wichita, Kansas, 미국, 67214
- Via Christi Cancer Center at Via Christi Regional Medical Center
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Wichita, Kansas, 미국, 67208
- Associates in Womens Health, PA - North Review
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Winfield, Kansas, 미국, 67156
- Cancer Center of Kansas, PA - Winfield
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Kentucky
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Lexington, Kentucky, 미국, 40503-9985
- Central Baptist Hospital
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Maine
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York Village, Maine, 미국, 03909
- York Hospital's Oncology Treatment Center
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Maryland
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Baltimore, Maryland, 미국, 21244
- Kaiser Permanente at Woodlawn Medical Center
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Elkton MD, Maryland, 미국, 21921
- Union Hospital of Cecil County
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Gaithersburg, Maryland, 미국, 20879
- Kaiser Permanente - Gaithersburg Medical Center
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Largo, Maryland, 미국, 20774
- Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility
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Silver Spring, Maryland, 미국, 20910
- Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- Tufts Medical Center Cancer Center
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Hyannis, Massachusetts, 미국, 02601
- Cape Cod Hospital
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New Jersey
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Elizabeth, New Jersey, 미국, 07207
- Trinitas Comprehensive Cancer Center at Trinitas Hospital
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Voorhees Township, New Jersey, 미국, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Staten Island, New York, 미국, 10305
- Nalitt Cancer Institute at Staten Island University Hospital
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North Carolina
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Greenville, North Carolina, 미국, 27834
- Leo W. Jenkins Cancer Center at ECU Medical School
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North Dakota
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Fargo, North Dakota, 미국, 58122
- CCOP - MeritCare Hospital
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Ohio
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Columbus, Ohio, 미국, 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, 미국, 38501
- Cookeville Regional Medical Center
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Texas
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Houston, Texas, 미국, 77030-4009
- M. D. Anderson Cancer Center at University of Texas
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Laredo, Texas, 미국, 78045
- Doctor's Hospital of Laredo
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Virginia
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Fairfax, Virginia, 미국, 22033
- Kaiser Permanente Medical Center - Fair Oaks
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McLean, Virginia, 미국, 22102
- Kaiser Permanente Tysons Corner Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
|
|
실험적: 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
다른 이름들:
Complete physical therapy-focused intervention
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Who Were Lymphedema-free 18 Months After Randomization
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Electra D. Paskett, PhD, Ohio State University Comprehensive Cancer Center
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2006년 6월 1일
기본 완료 (실제)
2015년 11월 1일
연구 완료 (실제)
2017년 6월 15일
연구 등록 날짜
최초 제출
2006년 9월 13일
QC 기준을 충족하는 최초 제출
2006년 9월 13일
처음 게시됨 (추정된)
2006년 9월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 18일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 27일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CALGB-70305
- U10CA037447 (미국 NIH 보조금/계약)
- CDR0000494652 (레지스트리 식별자: NCI Physician Data Query)
- NCI-2009-00488 (레지스트리 식별자: NCI Clinical Trial Reporting Program)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Individual Participant Data Set
연구 데이터/문서
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .