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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00376597
First received: September 13, 2006
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Breast Cancer
Lymphedema
Perioperative/Postoperative Complications
Behavioral: exercise intervention
Other: educational intervention
Procedure: assessment of therapy complications
Procedure: complementary or alternative medicine procedure
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of lymphedema as assessed by changes in arm circumference [ Designated as safety issue: No ]
  • Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm [ Designated as safety issue: No ]
  • Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score [ Designated as safety issue: No ]
  • Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: June 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376597

  Show 76 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Electra D. Paskett, PhD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00376597     History of Changes
Other Study ID Numbers: CDR0000494652, CALGB-70305
Study First Received: September 13, 2006
Last Updated: December 19, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Lymphedema
Postoperative Complications
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014