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Clinical Trials (PDQ®)

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
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedSupportive careActive18 and overNCI, OtherCDR0000494652
CALGB-70305, NCT00376597

Trial Description

Summary

RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.

Further Study Information

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, 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 exercises.

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

Eligibility 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

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 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

PRIOR CONCURRENT THERAPY:

  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

National Cancer Institute

Electra D. PaskettStudy Chair

Trial Sites

U.S.A.
Kentucky
  Lexington
 Central Baptist Hospital
 Peter S. Tate Ph: 859-260-6425
North Carolina
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
Pennsylvania
  Dubois
 Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
 Carmine Marchioli Ph: 570-342-3675ext218
Texas
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Jamie L Wagner
  Email: jwagner@mdanderson.org
West Virginia
  Huntington
 St. Mary's Regional Cancer Center at St. Mary's Medical Center
 James H Morgan
  Email: calgbco@calgb.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00376597
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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