N/A
N=75
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
Lymphedema · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00383500 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy — 19; 21; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flexitouch (Device); Class 1 compression garment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy |
19; 21; 22 | — |
| PRIMARY Incidence of Lymphedema (Newly-developing) |
1; 5; 5 | — |
Summary
To compare the effectiveness of usual treatments for lymphedema [massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.
Eligibility Criteria
Inclusion Criteria
- Unilateral breast cancer
- Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.
- Referred to the surgeons of the Stanford University Breast Cancer Program
- Capacity to provide informed consent.
- All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.
Exclusion Criteria
- Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- Recurrent breast cancer or other forms of pre-existing lymphedema.
Data sourced from ClinicalTrials.gov (NCT00383500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.