“With the enrollment of our first patient, we are pleased to initiate the largest randomized, controlled clinical trial ever conducted for the treatment of head and neck cancer-related lymphedema,” said
The trial will compare the short- and long-term effectiveness of Tactile Medical’s Flexitouch Plus system to usual care, such as complete decongestive therapy (“CDT”), for the management of lymphedema and fibrosis in head and neck cancer survivors. It will consist of approximately 250 subjects enrolled at six clinical sites:
Subjects enrolled in the trial will be randomized to one of two arms, where they will either self-administer once daily treatment with Flexitouch Plus or receive usual care as would typically be directed at their site, which may include CDT by a lymphedema therapist or other conservative management measures as directed by the therapist. The trial’s primary outcome measures will include the assessment of swelling/inflammation, symptom burden and functional impairment, including swallowing; quality of life; work productivity; and activity impairment and body image via various measures. Short-term effectiveness will be evaluated at two months and long-term effectiveness will be evaluated at four and six months.
“More than 90% of patients treated for head and neck cancer develop lymphedema1 – resulting in swelling, fibrosis, difficulty swallowing, pain and other symptoms impacting quality of life – with few viable options for long-term treatment,” said Dr.
For additional information about the trial, please visit: https://tactilemedical.com/head-and-neck-lymphedema-clinical-trial/
Lymphedema is a chronic disease in which excess fluid accumulates in areas of the body when lymphatic vessels do not work efficiently or have been damaged. An estimated 1.4 million
About Flexitouch® Plus
The Flexitouch Plus system has been clinically proven to stimulate the lymphatic system. It delivers a noninvasive therapy that patients can administer themselves at home. Tens of thousands of patients with lymphedema in the limbs and trunk areas have benefited from the Flexitouch system since its introduction in 2002. In 2017,
About Tactile Medical
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1 Control group patients experienced a statistically significant increase in pain while Flexitouch group remained stable. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy B. A Prospective Study of the Lymphedema and Fibrosis Continuum in Patients with Head and Neck Cancer. Lymphat Res Biol. 2016;14(4):198–205.
Mike Piccinino, CFA, IRC Managing Director Westwicke [email protected]
Source: Tactile Systems Technology, Inc.