4 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if treating the lymphatics in head and neck cancer survivors before clinical diagnosis of lymphedema will prevent its development or progression. The main questions it aims to answer are: * Does early lymphatic treatment, before onset of clinical symptoms, prevent the development of head and neck lymphedema? * Does dermal lymphatic backflow provide an early indication of lymphedema and its response to treatment? Over the course of one year, participants will undergo several sessions near-infrared fluorescence lymphatic imaging to assess whether they have abnormal dermal lymphatic backflow following head and neck cancer treatment. Subjects will be divided into two groups, a treated and a control group. The treated group will be asked to complete daily sessions of pneumatic compression therapy at home, while the control group will receive standard-of-card treatment after clinical diagnosis of lymphedema. Researchers will compare the incidence of lymphedema between the two groups to see if treatment before diagnosis prevents the development and progression of head and neck lymphedema.
This will be a prospective, randomized controlled study of \~60 adult patients who have undergone a laryngectomy, neck dissection, maxillectomy or mandibulectomy surgical procedure for the treatment of head and neck cancer at Our Lady of the Lake Hospital and have been referred by their physician for evaluation of head and neck lymphedema while serving as an inpatient. Consenting patients will be evaluated by certified speech and language pathologists trained to ascertain lymphedema severity using a series of visual and tangible measurements immediately following surgery and randomized into two cohorts, one receiving the complete decongestive therapy regimen and the other not receiving this specific combination treatment for their edema. Facial and neck measurements will be taken at baseline following surgery and at several points prior to and at discharge as well as at the 2 week follow up visit to the clinic. Measurements and overall change/reduction in edema will be compared between the cohorts.
To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.
Injuries to the face caused by traumatic events such as motor vehicle collisions, assault, and falls can result in facial trauma, which can result in swelling and disfiguration that impairs the important functions of the face, sometimes to a life threatening degree. These injures and the resultant swelling can also precipitate psychological and social consequences. Lymphedema is an abnormal amount of fluid that causes swelling, usually in the arms or legs. The most common presentation of lymphedema is in the upper extremities due to breast cancer treatment (Maclellean RA et al). As such, standards of care for management of lymphedema are primarily derived from the cancer research literature and involve the extremities (Moffatt CJ. 2003 QJM). The current gold standard treatment for patients with extremity lymphedema is complete decongestive therapy (CDT) (Zuther 2013). CDT is a multimodal therapy consisting of four components: manual lymph drainage, compression wrapping, exercise, and skin care (Zuther 2013).These same therapeutic techniques of CDT have been employed at Our Lady of the Lake Regional Medical Center (OLOLRMC) and adapted to treat patients with facial trauma with anecdotally good results primarily related to cosmesis. To the best of our knowledge, no clinical studies examining the effect of lymphedema treatment in the management of blunt facial trauma currently exist.. Beyond the consideration of cosmesis, we also seek to determine if this intervention improves clinical outcomes such as time to swallowing and reduced time utilizing mechanical ventilation. This study will prospectively evaluate the use of complete decongestive therapy to test the hypothesis that this intervention results in improved clinical outcomes in patients with blunt facial trauma.