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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376597
• Other study ID #: CALGB-70305
• Secondary ID: CDR0000494652NCI
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: June 15, 2017

Study information

• Verified date: January 2019
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: June 15, 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema

Intervention

Other:
• quality of life assessment
Ancillary studies
• educational intervention
Receive lymphedema educational materials

Procedure:
• Physical therapy
Complete physical therapy-focused intervention

Locations

Country	Name	City	State
United States	Kaiser Permanente at Woodlawn Medical Center	Baltimore	Maryland
United States	Tufts Medical Center Cancer Center	Boston	Massachusetts
United States	St. Vincent's Medical Center	Bridgeport	Connecticut
United States	East Bay Radiation Oncology Center	Castro Valley	California
United States	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Resurrection Medical Center	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Cancer Care Center at John Muir Health - Concord Campus	Concord	California
United States	Cookeville Regional Medical Center	Cookeville	Tennessee
United States	North Broward Medical Center	Deerfield Beach	Florida
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Trinitas Comprehensive Cancer Center at Trinitas Hospital	Elizabeth	New Jersey
United States	Alexian Brothers Radiation Oncology	Elk Grove Village	Illinois
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Kaiser Permanente Medical Center - Fair Oaks	Fairfax	Virginia
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas
United States	Valley Medical Oncology	Fremont	California
United States	Kaiser Permanente - Gaithersburg Medical Center	Gaithersburg	Maryland
United States	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility	Largo	Maryland
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Kaiser Permanente Tysons Corner Medical Center	McLean	Virginia
United States	Cancer Center of Kansas, PA - McPherson	McPherson	Kansas
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	Bay Area Breast Surgeons, Incorporated	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Highland General Hospital	Oakland	California
United States	Larry G Strieff MD Medical Corporation	Oakland	California
United States	Tom K Lee, Incorporated	Oakland	California
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Sacred Heart Cancer Center at Sacred Heart Hospital	Pensacola	Florida
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Michiana Hematology-Oncology, PC - South Bend	South Bend	Indiana
United States	Nalitt Cancer Institute at Staten Island University Hospital	Staten Island	New York
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	John Muir/Mt. Diablo Comprehensive Cancer Center	Walnut Creek	California
United States	Kaiser Permanente at Capitol Hill Medical Center	Washington	District of Columbia
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	York Hospital's Oncology Treatment Center	York	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Were Lymphedema-free 18 Months After Randomization	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
Secondary	Change From Baseline at 18 Months in Arm Circumference at the Site of Greatest Difference	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
Secondary	Agreement Between Patients' Self-report of Swelling and the Extent of Circumferential Measurement Difference Between the Treated Side and the Contralateral Arm	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
Secondary	Health-related Quality of Life as Assessed by FACT-B +4 Score	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
Secondary	Adherence to Lymphedema Prevention Exercises, Lymphedema Knowledge, Range of Motion, and Arm Strength	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