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NCT00376597

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Not specified

Start Date

2006-06

Completion Date

2017-06-15

Last Updated

2026-05-18

Healthy Volunteers

Conditions

Lymphedema

Interventions

OTHER

quality of life assessment

Ancillary studies

OTHER

educational intervention

Receive lymphedema educational materials

PROCEDURE

Physical therapy

Complete physical therapy-focused intervention

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

Locations (76)

East Bay Radiation Oncology Center

Castro Valley, California, United States

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, United States

Valley Medical Oncology

Fremont, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

El Camino Hospital Cancer Center

Mountain View, California, United States

Highland General Hospital