|
|
Randomized Study of Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I-III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
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
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
No phase specified
|
|
|
|
Educational/Counseling/Training, Treatment
|
|
|
|
Active
|
|
|
|
18 and over
|
|
|
|
NCI
|
|
|
|
CALGB-70305 CALGB 70305, NCT00376597
|
|
|
Special Category:
NCI Web site featured trial Objectives Primary - 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.
Secondary - 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 interventions.
- 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, range of motion, and arm strength.
Entry Criteria Disease Characteristics:
- 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) available
- Scheduled to undergo axillary node dissection with ≥ 10 nodes removed
- No sentinel axillary node dissection only
- Hormone receptor status not specified
Prior/Concurrent Therapy:
- See Disease Characteristics
- No prior double mastectomy, axillary node dissection, and/or radiotherapy involving both arms
- May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection
- Any type of radiotherapy to the breast or axilla allowed
- Neoadjuvant treatment for this cancer allowed
Patient Characteristics:
- 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 reduces 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
Expected Enrollment 560A total of 560 patients will be accrued for this study. Outcomes Primary Outcome(s)Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months)
Secondary Outcome(s)Severity of lymphedema as assessed by changes in arm circumference Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the
treated side and the contralateral arm Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score Adherence to lymphedema prevention exercises, lymphedema
knowledge, range of motion, and arm strength
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 and receive a 15-minute video that reinforces information and exercises.
Trial Contact Information
Trial Lead Organizations Cancer and Leukemia Group B | | | Electra Paskett, PhD, Protocol chair | | | | Trial Sites
|
|
|
|
U.S.A. |
|
California |
|
|
Castro Valley |
|
| | | | | | | | East Bay Radiation Oncology Center |
| | James Feusner, MD | |
| | Valley Medical Oncology Consultants - Castro Valley |
| | James Feusner, MD | |
|
|
Fremont |
|
| | Valley Medical Oncology |
| | James Feusner, MD | |
|
|
Martinez |
|
| | Contra Costa Regional Medical Center |
| | James Feusner, MD | |
|
|
Oakland |
|
| | Alta Bates Summit Medical Center - Summit Campus |
| | Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus | |
| | Bay Area Breast Surgeons, Incorporated |
| | James Feusner, MD | |
| | CCOP - Bay Area Tumor Institute |
| | James Feusner, MD | |
| | Larry G Strieff MD Medical Corporation |
| | James Feusner, MD | |
| | Tom K Lee, Incorporated |
| | James Feusner, MD | |
|
|
Pleasanton |
|
| | Valley Care Medical Center |
| | James Feusner, MD | |
| | Valley Medical Oncology Consultants - Pleasanton |
| | James Feusner, MD | |
|
Delaware |
|
|
Lewes |
|
| | | Tunnell Cancer Center at Beebe Medical Center |
| | Clinical Trials Office - Tunnell Cancer Center | |
|
|
Newark |
|
| | CCOP - Christiana Care Health Services |
| | Clinical Trial Office - CCOP - Christiana Care Health Services | |
|
District of Columbia |
|
|
Washington |
|
| | | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center |
| | Clinical Trials Office - Lombardi Comprehensive Cancer Center | |
|
Illinois |
|
|
Chicago |
|
| | | University of Chicago Cancer Research Center |
| | Clinical Trials Office - University of Chicago Cancer Research Center | |
|
|
Harvey |
|
| | Ingalls Cancer Care Center at Ingalls Memorial Hospital |
| | Clinical Trials Office - Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
|
Maryland |
|
|
Elkton MD |
|
| | | Union Hospital Cancer Program at Union Hospital |
| | Stephen Grubbs, MD | |
|
Michigan |
|
|
Battle Creek |
|
| | | Battle Creek Health System Cancer Care Center |
| | Marianne Lange, MD | |
|
|
Big Rapids |
|
| | Mecosta County Medical Center |
| | Marianne Lange, MD | |
|
|
Grand Rapids |
|
| | Butterworth Hospital at Spectrum Health |
| | Marianne Lange, MD | |
| | CCOP - Grand Rapids |
| | Marianne Lange, MD | |
| | Lacks Cancer Center at Saint Mary's Health Care |
| | Marianne Lange, MD | |
|
|
Holland |
|
| | Holland Community Hospital |
| | Marianne Lange, MD | |
|
|
Muskegon |
|
| | Hackley Hospital |
| | Marianne Lange, MD | |
|
|
Traverse City |
|
| | Munson Medical Center |
| | Marianne Lange, MD | |
|
|
Wyoming |
|
| | Metro Health Hospital |
| | Marianne Lange, MD | |
|
Missouri |
|
|
Columbia |
|
| | | Ellis Fischel Cancer Center at University of Missouri - Columbia |
| | Clinical Trial Office - Ellis Fischel Cancer Center | |
|
New Jersey |
|
|
Voorhees |
|
| | | Cancer Institute of New Jersey at Cooper - Voorhees |
| | Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees | |
|
North Carolina |
|
|
Goldsboro |
|
| | | Wayne Memorial Hospital, Incorporated |
| | James Atkins, MD | |
|
|
Pinehurst |
|
| | FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center |
| | Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
|
|
Winston-Salem |
|
| | Wake Forest University Comprehensive Cancer Center |
| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
|
Ohio |
|
|
Columbus |
|
| | | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
| | Clinical Trials Office - OSU Comprehensive Cancer Center | |
| Email:
osu@emergingmed.com |
|
South Carolina |
|
|
Greenville |
|
| | | CCOP - Greenville |
| | Jeffrey Giguere, MD, FACP | |
|
Vermont |
|
|
Burlington |
|
| | | Fletcher Allen Health Care - University Health Center Campus |
| | Clinical Trials Office - Fletcher Allen Health Care | |
|
West Virginia |
|
|
Huntington |
|
| | | St. Mary's Regional Cancer Center at St. Mary's Medical Center |
| | James Morgan, III | |
|
Related Information Featured trial article
Registry Information | | Official Title | | A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer | | Trial Start Date | | 2006-06-30 | | Trial Completion Date | | 2012-12-31 (estimated) | | Registered in ClinicalTrials.gov | | NCT00376597 | | Date Submitted to PDQ | | 2006-06-30 | | Information Last Verified | | 2009-01-24 | | NCI Grant/Contract Number | | CA77658 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
|