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
Condition: Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema
Intervention: quality of life assessment; educational intervention; Physical therapy
Intervention description: Ancillary studies; Receive lymphedema educational materials; Complete physical therapy-focused intervention
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 568.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lymphedema; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

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.
    

Eligibility criteria:

        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