This randomized pilot clinical trial studies how well negative pressure massage works in decreasing lymphedema in patients with breast cancer. A negative pressure massage device such as PhysioTouch, may be safe and effective at decreasing swelling, improving the condition of the skin, and improving movement in the arms of women with lymphedema, compared to manual lymphatic drainage massage.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03252145.
PRIMARY OBJECTIVES:
I. To determine the recruitment and retention rates for both arms of this 4-week pilot study of a novel lymphedema (LE) treatment using a negative pressure device. (Aim 1)
II. To evaluate for treatment-emergent adverse events. (Aim 2)
SECONDARY OBJECTIVES:
I. To determine effect sizes for treatment outcomes, comparing changes in the intervention group to changes in the control group, following the 4-week study. (Aim 3)
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive negative pressure massage via PhysioTouch over 60 minutes 2-3 times per week for 4-6 weeks.
GROUP II: Patients receive manual lymph drainage massage over 60 minutes 2-3 times per week for 4-6 weeks.
After completion of study, patients are followed up at 4 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUCSF Medical Center-Mount Zion
Principal InvestigatorBetty Smoot
