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A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer, Lymphedema, Perioperative/Postoperative Complications

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Trial Information

A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer



- Determine the efficacy of a comprehensive program of tailored exercise, lymphedema
prevention patient education, and counseling vs lymphedema prevention patient education
only in reducing the incidence of lymphedema in women with stage I-III breast cancer
who are undergoing axillary lymph node dissection.


- Compare the severity of lymphedema, in terms of changes in arm circumference at the
site of greatest difference as a continuous variable, in patients undergoing these

- Assess the agreement between patients' self-report of swelling (mild, moderate, or
severe) and the extent of circumferential measurement difference between the treated
side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥
0.5 and < 2 inches vs ≥ 2 inches).

- Compare the health-related quality of life of these patients.

- Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, and
range of motion.

OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization
is the participating center. Participating centers are stratified according to the annual
number of patients with stage I-III breast cancer who undergo axillary node dissection at
the center (small vs moderate vs large number of patients) and are randomized to 1 of 2
arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified
participating center.

All patients complete questionnaires prior to surgery regarding lymphedema knowledge,
health-related quality of life, fear of cancer recurrence, self-efficacy, body-image,
self-report of range of motion, arm circumference, and demographics. Patients then undergo
surgery, which must include axillary node dissection.

- 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 exercise regimen,
receive a refrigerator magnet, and a 15-minute video that reinforces information and

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of breast cancer

- Newly diagnosed disease

- Stage I-III disease

- No diagnosed lymphedema

- Must have arm measurements for axilla, elbow, and wrist that fall within the ranges
for one of six sleeve sizes (i.e., all three measurments must be found in one column)

- Scheduled to undergo axillary node dissection with ≥ 10 nodes removed

- No sentinel axillary node dissection only

- Hormone receptor status not specified


- Female

- Menopausal status not specified

- No documented cardiac conduction disturbances, unstable angina, dementia, or any
other chronic disease that, in the opinion of the investigator, significantly
increases mortality over the next 2 years

- May not be currently homebound or dependent upon a walker or wheelchair for mobility

- Able to participate in a mild exercise program

- No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in
situ, 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 carcinoma of the skin are eligible


- See Disease Characteristics

- No prior double mastectomy, axillary node dissection, and/or radiotherapy involving
both arms

- Prior treatment (i.e., surgergy and/or radiotherapy) on the contralateral arm
allowed provided it is documented appropriately

- May be enrolled on other treatment trials except surgery trials where one treatment
arm involves full axillary node dissection

- Patients enrolled on ACOSOG-Z1071 allowed

- Any type of radiotherapy to the breast or axilla allowed

- Neoadjuvant treatment for this cancer allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months)

Safety Issue:


Principal Investigator

Electra D. Paskett, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center



Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • Lymphedema
  • Perioperative/Postoperative Complications
  • lymphedema
  • perioperative/postoperative complications
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms
  • Lymphedema
  • Postoperative Complications



University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
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Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Tallahassee Memorial HospitalTallahassee, Florida  32308
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
John Muir/Mt. Diablo Comprehensive Cancer CenterWalnut Creek, California  94598
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Bettendorf, Iowa  52722
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Doctor's Hospital of LaredoLaredo, Texas  78041
Highland General HospitalOakland, California  94602
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
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Lawrence Memorial HospitalLawrence, Kansas  66044
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Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Resurrection Medical CenterChicago, Illinois  60631
Nalitt Cancer Institute at Staten Island University HospitalStaten Island, New York  10305
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Alexian Brothers Radiation OncologyElk Grove Village, Illinois  60007
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
York Hospital's Oncology Treatment CenterYork, Maine  03909
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Cancer Care Center at John Muir Health - Concord CampusConcord, California  94524-4110
Holy Cross HospitalSilver Spring, Maryland  20910
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Tufts Medical Center Cancer CenterBoston, Massachusetts  02111
North Broward Medical CenterDearfield Beach, Florida  33064-3596
AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland CampusPomona, New Jersey  08240
Trinitas Comprehensive Cancer Center at Trinitas HospitalElizabeth, New Jersey  07207
Cookeville Regional Medical CenterCookeville, Tennessee  38501
Cancer Center of Kansas, PA - McPhersonMcPherson, Kansas  67460
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