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



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer, Hospital
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:June 2006
End Date:June 15, 2017

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
76
sites
800 W. Laurel
Independence, Kansas 67301
620-331-4099
Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
?
mi
from
Independence, KS
Click here to add this to my saved trials
600 Moye Boulevard
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
1240 S Old Dixie Hwy
Jupiter, Florida 33458
(561) 263-4400
Ella Milbank Foshay Cancer Center at Jupiter Medical Center The Foshay Cancer Center is one...
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
902 Savannah Road
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
?
mi
from
Lewes, DE
Click here to add this to my saved trials
4300 Alton Road
Miami Beach, Florida 33140
(305) 674-2625
CCOP - Mount Sinai Medical Center The Mount Sinai Community Clinical Oncology Program (MSCCOP) is...
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
1545 Airport Boulevard
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeport, Connecticut 06606
?
mi
from
Bridgeport, CT
Click here to add this to my saved trials
20126 Stanton Ave
Castro Valley, California 94546
(510) 581-0556
East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
20055 Lake Chabot Rd #130
Castro Valley, California 94546
(510) 888-0657
Valley Medical Oncology Consultants - Castro Valley Valley Medical Oncology Consultants (VMOC) has been helping...
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
Chicago, Illinois 60631
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Concord, CA
Click here to add this to my saved trials
Cookeville, Tennessee 38501
?
mi
from
Cookeville, TN
Click here to add this to my saved trials
Deerfield Beach, Florida 33064
?
mi
from
Deerfield Beach, FL
Click here to add this to my saved trials
2020 Central Ave
Dodge City, Kansas 67801
(620) 227-2488
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
Dodge City, KS
Click here to add this to my saved trials
700 West Central
El Dorado, Kansas 67042
(316) 889-0099
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
?
mi
from
El Dorado, KS
Click here to add this to my saved trials
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Elk Grove Village, Illinois 60007
?
mi
from
Elk Grove Village, IL
Click here to add this to my saved trials
Elkton, Maryland 21921
?
mi
from
Elkton, MD
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Fort Scott, Kansas 66701
(620) 223-8589
Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Fort Scott, KS
Click here to add this to my saved trials
Fremont, California 94538
?
mi
from
Fremont, CA
Click here to add this to my saved trials
?
mi
from
Gaithersburg, MD
Click here to add this to my saved trials
One Ingalls Drive
Harvey, Illinois 60426
708.333.2300
Ingalls Cancer Care Center at Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hyannis, Massachusetts 02601
?
mi
from
Hyannis, MA
Click here to add this to my saved trials
750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Kingman, KS
Click here to add this to my saved trials
1007 LINCOLNWAY
La Porte, Indiana 46350
219.326.1234
Center for Cancer Therapy at LaPorte Hospital and Health Services United in our mission, the...
?
mi
from
La Porte, IN
Click here to add this to my saved trials
Laredo, Texas 78041
?
mi
from
Laredo, TX
Click here to add this to my saved trials
?
mi
from
Largo, MD
Click here to add this to my saved trials
325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
?
mi
from
Lawrence, KS
Click here to add this to my saved trials
1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
315 W. 15th St.
Liberal, Kansas 67905
(620) 629-6727
Cancer Center of Kansas, PA - Liberal Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Liberal, KS
Click here to add this to my saved trials
2500 Alhambra Ave
Martinez, California 94553
(925) 370-5000
Contra Costa Regional Medical Center Contra Costa Health Services is the largest department of County...
?
mi
from
Martinez, CA
Click here to add this to my saved trials
?
mi
from
McLean, VA
Click here to add this to my saved trials
1000 Hospital Dr.
McPherson, Kansas 67460
(620 )504-6630
Cancer Center of Kansas, PA - McPherson The physicians of Cancer Center are hematologists and...
?
mi
from
McPherson, KS
Click here to add this to my saved trials
5215 Holy Cross Parkway
Mishawaka, Indiana 46545
574-335-5000
Saint Joseph Regional Medical Center Saint Joseph Regional Medical Center is a not-for-profit, multi-hospital health...
?
mi
from
Mishawaka, IN
Click here to add this to my saved trials
?
mi
from
Moline, IL
Click here to add this to my saved trials
500 John Deere Road
Moline, Illinois 61265
(309) 779-5000
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Located at 500 John...
?
mi
from
Moline, IL
Click here to add this to my saved trials
2490 Hospital Dr
Mountain View, California 94040
(650) 988-8338
El Camino Hospital Cancer Center At El Camino Hospital, we are fortunate to have an...
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
4701 Ogletown-Stanton Road
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
?
mi
from
Newark, DE
Click here to add this to my saved trials
720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Newton, KS
Click here to add this to my saved trials
350 Hawthorne Ave
Oakland, California 94609
(510) 655-4000
Alta Bates Summit Medical Center - Summit Campus Alta Bates Summit Medical Center offers comprehensive...
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oakland, California 94609
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oakland, California 94609
?
mi
from
Oakland, CA
Click here to add this to my saved trials
400 30th Street, Suite 301
Oakland, California 94609
(510) 465-8016
CCOP - Bay Area Tumor Institute he Bay Area Tumor Institute Community Clinical Oncology Program...
?
mi
from
Oakland, CA
Click here to add this to my saved trials
1411 E 31st St
Oakland, California 94602
(510) 437-4800
Highland General Hospital Highland Hospital is the largest campus of Alameda Health System. With 236...
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oakland, California 94609
?
mi
from
Oakland, CA
Click here to add this to my saved trials
1902 S. US Hwy 59
Parsons, Kansas 67357
(620) 421-2855
Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Parsons, KS
Click here to add this to my saved trials
124 Commodore, Ste. A
Pratt, Kansas 67124
(620) 672-2478
Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Pratt, KS
Click here to add this to my saved trials
600 S Santa Fe Ave
Salina, Kansas 67401
(785) 823-1521
Cancer Center of Kansas, PA - Salina Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Salina, KS
Click here to add this to my saved trials
2000 Vale Road
San Pablo, California 94806
(510) 970-5000
Doctors Medical Center - San Pablo Campus Doctors Medical Center is a full service, acute...
?
mi
from
San Pablo, CA
Click here to add this to my saved trials
Silver Spring, Maryland 20910
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
615 N Michigan St
South Bend, Indiana 46601
(574) 647-1000
Memorial Hospital of South Bend Memorial Hospital of South Bend is a community-owned, not-for-profit corporation...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
3975 William Richardson Dr
South Bend, Indiana 46601
(574) 204-7709
Michiana Hematology Oncology In 1968, medical oncologist Thomas Troeger, MD had a dream to advance...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
South Bend, Indiana 46601
?
mi
from
South Bend, IN
Click here to add this to my saved trials
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Walnut Creek, California 94598
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Washington, District of Columbia 20002
?
mi
from
Washington,
Click here to add this to my saved trials
3970 Reservoir Rd NW E501
Washington, District of Columbia 20007
(202) 687-2110
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Georgetown Lombardi Comprehensive Cancer Center, part...
?
mi
from
Washington,
Click here to add this to my saved trials
1323 N. A
Wellington, Kansas 67152
(620) 326-7453 Ext. 224
Cancer Center of Kansas, PA - Wellington Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Wellington, KS
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials
8710 W 13th St N # 100
Wichita, Kansas 67208
(316) 722-5141
Associates in Womens Health, PA - North Review On January 1, 1997, four prominent practices,...
?
mi
from
Wichita, KS
Click here to add this to my saved trials
1305 E 5th Ave
Winfield, Kansas 67156
(620) 221-6125
Cancer Center of Kansas, PA - Winfield Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Winfield, KS
Click here to add this to my saved trials
?
mi
from
York, ME
Click here to add this to my saved trials