This trial studies how well intensive lymphedema screening work in reducing the development rate of lymphedema in breast cancer patients. Lymphedema is a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen. Intensive and more frequent lymphedema screening may reduce the development rate of lymphedema and/or its side effects.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05056207.
PRIMARY OBJECTIVES:
I. To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade I lymphedema among breast cancer patients after axillary lymph node dissection (ALND) compared to routine screening.
SECONDARY OBJECTIVES:
I. To estimate the direct costs associated with the Lymphedema Screening Initiative.
II. To determine the association of the Initiative on patient productivity.
III. To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care.
IV. To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND.
V. To determine patient understanding of lymphedema-associated symptoms.
VI. To determine patient self-reported compliance with treatments and measures to prevent lymphedema.
VII. To analyze clinical and pathological features associated with the development of lymphedema.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients undergo arm size and volume measurement using a perometer once.
COHORT II: Patients undergo arm size and volume measurement using a perometer up to 5 times over 1 year.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSimona F. Shaitelman
