A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

NCT03332160 | Completed Results FDA Device

• 1 other identifier: 4030
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms; Head and Neck Cancer; Head and Neck Lymphedema

Keywords

Lymphedema; Cancer; Head Cancer; Neck Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Fidelity/Adherence Via Subject Diary

  Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring fidelity/adherence using a subject diary. Values represent a count of participants who met the prescribed use criteria by week. The prescribed use was defined as two 30 minute sessions in a day.

  From baseline to end of treatment at 8 weeks

• Adverse Events

  Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring adverse events using the CTCAE (v4.0). Values represent the count of events per adverse events category.

  From baseline to the end of treatment at 8 weeks

• Treatment Satisfaction

  Evaluate the feasibility and potential effectiveness of the Flexitouch head and neck garments by monitoring treatment satisfaction using a satisfaction survey. A survey assessed participants' perceived ability to control their head and neck lymphedema before (at baseline) and after the usage of the Flexitouch at 8 weeks. Values represent a count of participants who indicated good, very good, or excellent.

  From baseline to the end of treatment at 8 weeks

Secondary Outcomes (11)

• Reduction in Swelling/Inflammation - Endoscopy

  From baseline to the end of treatment at 8 weeks

• Reduction in Swelling/Inflammation - Cytokine Levels

  From baseline to the end of treatment at 8 weeks

• Reduction in Swelling/Inflammation - Digital Photography

  From baseline to the end of treatment at 8 weeks

• Reduction in Swelling/Inflammation - Grading of External Lymphedema

  From baseline to the end of treatment at 8 weeks

• Function - Jaw Range of Motion

  From baseline to the end of treatment at 8 weeks

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard home lymphedema care

Other: Standard home lymphedema care

Flexitouch head and neck lymphedema treatment system

EXPERIMENTAL

Daily treatment with Flexitouch® pneumatic compression device for treatment of head and neck lymphedema and standard home lymphedema care

Device: Flexitouch head and neck lymphedema treatment system

Interventions

Flexitouch head and neck lymphedema treatment system DEVICE

Pneumatic compression device cleared for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: lymphedema; primary lymphedema; post mastectomy edema; edema following trauma and sports injuries; post immobilization edema; venous insufficiency; reducing wound healing time; treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. The Flexitouch system and garments for head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.

Also known as: Flexitouch System

Flexitouch head and neck lymphedema treatment system

Standard home lymphedema care OTHER

May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tactile Medical: lead
• Vanderbilt University: collaborator

Study Sites (2)

SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lymphedema; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

This trial was designed as a pilot study and thus the sample size is small.

Results Point of Contact

• Title: Heather Smith
• Organization: Tactile Medical

HSmith@tactilemedical.com

612.800.5539

Study Officials

• Sheila Ridner, PhD, RN

  Vanderbilt University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 6, 2017
• Study Start: January 2, 2018
• Primary Completion: June 4, 2019
• Study Completion: July 31, 2019
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)