Flexitouch for Head and Neck Lymphedema: A Randomized Control Trial

Overview of a Vanderbilt randomized control trial comparing use of the Flexitouch system plus self-management with self-management alone for treatment of head and neck lymphedema.

Compared with self-management alone, Flexitouch HN therapy resulted in:

  • 24% decrease in external swelling (vs. 5% increase)
  • 4X greater improvement in swallowing solids
  • Stable pain (vs. increased pain)

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Authors: Sheila H. Ridner, Mary S. Dietrich, Jie Deng, Sandra L. Ettema & Barbara Murphy

Purpose:

Lymphedema associated with head and neck cancer (HNC) therapy causes adverse clinical outcomes. Standard treatment includes professionally administered complete decongestive therapy (CDT). Cost and availability of trained therapists are known barriers to therapy. Advanced pneumatic compression devices (APCD) may address these issues. A randomized, wait-list controlled trial was undertaken to evaluate an APCD in post-treatment HNC patients with lymphedema.

Material and methods:

Eligible patients had completed treatment for HNC, were disease free, and had lymphedema at enrollment. Participants were randomized to wait-list lymphedema self-management (standard of care) or lymphedema self-management plus the use of the APCD bid. Safety (CTCAE V4.0) and feasibility were primary endpoints; secondary endpoints included efficacy measure by objective examination and patient reported outcomes (symptoms, quality of life, function), adherence barriers, and satisfaction. Assessments were conducted at baseline and weeks 4 and 8.

Results:

Forty-nine patients were enrolled (wait-list n = 25; intervention n = 24). In total, forty-three patients completed the study. No device-related Serious Adverse Events were reported. Most patients used the APCD once per day, instead of the prescribed twice per day, citing time related factors as barriers to use. APCD use was associated with significant improvement in perceived ability to control lymphedema (p = 0.003) and visible external swelling (front view p < 0.001, right view p = 0.004, left p = 0.005), as well as less reported pain.

Conclusion:

This trial supports the safety and feasibility of the APCD for the treatment of secondary lymphedema in head and neck cancer patients. In addition, preliminary data supports efficacy.