This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in treating patients with lymphedema after chemoradiation for stage II-IV head and neck cancer. Lymphedema can be the result of surgery, radiation therapy, chemotherapy or any combination of these procedures. Internal lymphedema has been shown to negatively affect speech production, swallowing, respiration, and voice. Flexitouch is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides pressure changes to move lymph fluid from the impaired area toward healthy regions of the body. Complete decongestive therapy (CDT) is standard of care for treating external lymphedema and involves manual lymphatic drainage (MLD) performed by licensed therapists followed by compression therapy. CDT has long been used for treating lymphedema of the limbs. Combining a pneumatic compression system with standard of care manual lymphatic drainage may have positive effects on speech, voice, and swallowing.
PRIMARY OBJECTIVES: I. Compare success rates in reducing internal and external lymphedema using manual lymphatic drainage (MLD) versus use of a pneumatic compression device (PCD). Assess efficacy of PCD and MLD. II. Assess compliance of treatment in both groups. III. Assess changes in voice and swallowing in both groups. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP I: Patients undergo 32 minute treatments twice daily for 12 weeks using the FlexiTouch Plus System and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline. GROUP II: Patients undergo standard of care self-manual lymphatic drainage (technique instructions provided) twice daily for 12 weeks and treatment with a lymphedema therapist weekly on weeks 2-11. Patients undergo nasolaryngoscopy and videofluoroscopic swallow study at baseline.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Undergo self-manual lymphatic drainage
Ancillary studies
Undergo photographs of face and neck
Undergo skilled lymphedema treatment by a therapist
Undergo swallow study
Undergo Nasolaryngoscopy
Undergo compression therapy - Flexitouch Plus System is an advanced pneumatic compression device (APCD) that consists of a 2-piece garment that provides systematic and sequential pressure changes to move fluid to intact lymphatic chains.
Ancillary studies
Ancillary studies
Ancillary studies
Compare composite measurements of the face and neck for lymphatic drainage
Will be completed at baseline and at the conclusion of the study to assess and compare the effects of traditional manual lymphatic drainage to those from use of a pneumatic compression system.
Time frame: Change from baseline and up to 12 weeks
Change in lymphedema of the head and neck
A reduction in one grade on the Mayo Clinic Lymphedema - head and neck (HN) Grading Scale (MCLGS) or one stage on the MD Anderson Cancer Center (MDACC) grading system for lymphedema of the head and neck.
Time frame: Up to 12 weeks
Improvements on quality of life (QOL) function
Measured by QOL questionnaire and Facial and Neck Composite Measurements Status Scale: PSS-HN
Time frame: Up to 12 weeks
Improvements on voice function
Measured by Voice Handicap Index: VHI-10 and Consensus Aud- Perceptual Eval of Voice: CAPE-V
Time frame: Up to 12 weeks
Improvements on swallowing function
Measured by Videofluoroscopic Swallow Study, Functional Oral Intake Scale: FOIS, Eating Assessment Tool: EAT-10 and Performance
Time frame: Up to 12 weeks
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