Effects of a Pneumatic Compression Device in Post-Chemoradiation Head and Neck Cancer Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Primary Endpoint
- Compare composite measurements of the face and neck for lymphatic drainage
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completed definitive chemoradiation for Stage II or greater, histologically proven cancer of the oral cavity, oropharynx, hypopharynx, pharynx or larynx with a curative intent
- •Cognitive function adequate to understand and execute the elements of the protocol
- •Willingness and ability to return to Mayo Clinic for follow-up care per protocol
- •Resolution of acute dermatitis (skin must be intact without evidence of inflammation, infection or desquamation) as a result of chemoradiotherapy (CRT)
- •Must demonstrate oropharyngeal competency that would allow some oral intake
Exclusion Criteria
- •Prior surgery, radiation, chemotherapy, or immunotherapy for head or neck cancer
- •Acute radiation dermatitis, unhealed surgical wounds or surgical flap less than 2 months post-operative
- •Acute facial infection
- •Active congestive heart failure (CHF) or pulmonary edema
- •Symptomatic carotid artery disease or bradycardia
- •Increased intracranial pressure
- •History of multiple cerebrovascular accidents (CVAs) or transient ischemic attacks (TIAs)
- •> 50% internal carotid artery (ICA) blockage
- •Upper quadrant deep vein thrombosis
- •Known esophageal obstruction
- •Percutaneous endoscopic gastrostomy (PEG) tube dependence with no oral intake
- •Women of child-bearing potential
- •(Active) pregnancy
Arms & Interventions
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Consensus Auditory-Perceptual Evaluation of Voice (Other)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Diagnostic Imaging (Procedure)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Lymphedema Management (Other)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Modified Barium Swallow (Procedure)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Nasopharyngeal Laryngoscopy (Procedure)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Pneumatic Compression Therapy (Device)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Quality-of-Life Assessment (Other)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Questionnaire Administration (Other)
Group I (pneumatic therapy, lymphedema management)
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.
Intervention: Voice Handicap Index-10 (Other)
Group II (standard of care, lymphedema management)
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.
Intervention: Best Practice (Other)
Group II (standard of care, lymphedema management)
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.
Intervention: Consensus Auditory-Perceptual Evaluation of Voice (Other)
Group II (standard of care, lymphedema management)
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.
Intervention: Diagnostic Imaging (Procedure)
Group II (standard of care, lymphedema management)
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.
Intervention: Lymphedema Management (Other)
Group II (standard of care, lymphedema management)
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.
Intervention: Modified Barium Swallow (Procedure)
Group II (standard of care, lymphedema management)
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.
Intervention: Nasopharyngeal Laryngoscopy (Procedure)
Group II (standard of care, lymphedema management)
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.
Intervention: Quality-of-Life Assessment (Other)
Group II (standard of care, lymphedema management)
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.
Intervention: Questionnaire Administration (Other)
Group II (standard of care, lymphedema management)
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.
Intervention: Voice Handicap Index-10 (Other)
Outcomes
Primary Outcomes
Compare composite measurements of the face and neck for lymphatic drainage
Time Frame: Change from baseline and up to 12 weeks
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.
Change in lymphedema of the head and neck
Time Frame: Up to 12 weeks
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.
Secondary Outcomes
- Improvements on swallowing function(Up to 12 weeks)
- Improvements on quality of life (QOL) function(Up to 12 weeks)
- Improvements on voice function(Up to 12 weeks)