Clinical trial NCT03332160: A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
Official title: A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Neoplasms
Head and Neck Cancer
Head and Neck Lymphedema
Keywords: Lymphedema
Cancer
Head Cancer
Neck Cancer
Head and Neck Cancer
Lead sponsor: Tactile Medical
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
First posted: 2017-11-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the feasibility and potential effectiveness of the Flexitouch head and neck treatment plus standard home care compared to standard home care regimen alone.

Detailed description: This study is an open-label, multi-site, stratified randomized, wait list control, pilot study. The study will be conducted at up to 2 sites in the United States and enroll 40 subjects with a diagnosis of head and neck lymphedema following treatment for head and neck cancer. Subjects randomized to receive daily treatment with the Flexitouch pneumatic compression device and home care regimen (SOC) will be seen at baseline and weeks 1, 4, and 8. Subjects randomized to the wait list arm will be seen at baseline and weeks 1, 4, and 8 while receiving SOC treatment. Assessments will include fidelity, satisfaction, symptoms, swelling/inflammation, function, and QOL.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* A previous diagnosis of histologically defined head and neck cancer.
* A diagnosis of head and neck lymphedema.
* Must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation.
* Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved.
* The head and neck garments must fit appropriately. For patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy.
* The subject must have experienced at least one of the following:
* Completion of phase 1 lymphedema care in the past 8 weeks;
* The inability to participate/complete phase 1 care due to:
* Lack of available therapist/clinic,
* Lack of insurance coverage or funding to support cost of care.

Exclusion Criteria:

* Uncontrolled hyperthyroidism or parathyroidism (for which endocrinologist recommends against neck compression).
* Carotid sinus hypersensitivity syndrome.
* Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness).
* Symptomatic bradycardia in the absence of a pacemaker.
* Internal jugular venous thrombosis, acute or within 3 months.
* Increased intracranial pressure or other contraindications to internal or external jugular venous compression.
* Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative.
* Facial or head and neck dermal metastasis.
* Acute facial infection (e.g., facial or parotid gland abscess).
* Any condition in which increased venous and lymphatic return is undesirable.
* History of pulmonary edema or decompensated congestive heart failure with in six (6) week of enrollment.
* Subject is pregnant or trying to become pregnant.

Primary outcomes:
measure: Fidelity/Adherence Via Subject Diary
timeFrame: From baseline to end of treatment at 8 weeks
measure: Adverse Events
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Treatment Satisfaction
timeFrame: From baseline to the end of treatment at 8 weeks
Secondary outcomes:
measure: Reduction in Swelling/Inflammation - Endoscopy
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Reduction in Swelling/Inflammation - Cytokine Levels
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Reduction in Swelling/Inflammation - Digital Photography
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Reduction in Swelling/Inflammation - Grading of External Lymphedema
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Function - Jaw Range of Motion
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Function - Neck Disability Index
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Function - Voice Handicap Index
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Function - Cervical and Shoulder Range of Motion
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Symptoms - Vanderbilt Head and Neck Symptom Survey
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Quality of Life - Linear Analog Self-Assessment
timeFrame: From baseline to the end of treatment at 8 weeks
measure: Symptoms - Lymphedema Symptom Intensity and Distress Survey
timeFrame: From baseline to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Nursing
name: Sheila Ridner, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: