Treatment Trials

23 Clinical Trials for Various Conditions

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RECRUITING
Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]
Description

The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.

RECRUITING
Comparing Two Ways to Manage Head and Neck Lymphedema
Description

This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.

ACTIVE_NOT_RECRUITING
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
Description

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.

TERMINATED
Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression
Description

The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.

COMPLETED
Complete Decongestive Therapy on Head and Neck Lymphedema
Description

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.

COMPLETED
Low-Level Laser in Treatment of Head and Neck Lymphedema: A Pilot Study
Description

The purpose of this pilot clinical trial is to evaluate the feasibility of the use of low-level laser for head and neck cancer survivors with lymphedema.

TERMINATED
A Registry to Evaluate the Flexitouch System and Flexitouch Plus for Treatment of Head and Neck Lymphedema
Description

The objective of this registry is to evaluate the long term effectiveness of the Flexitouch System and Flexitouch Plus in those with head and neck lymphedema. This outcome data will include information regarding each subject's medical history, symptoms, quality of life, pain, range of motion (ROM), swelling, ease of use, treatment satisfaction, treatment compliance, and adverse events.

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

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.

COMPLETED
Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema
Description

Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.

COMPLETED
Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema
Description

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

COMPLETED
Low-Level Laser in Head and Neck Chronic Lymphedema
Description

The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.

ENROLLING_BY_INVITATION
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Description

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.

NOT_YET_RECRUITING
Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
Description

The U.S. Food and Drug Administration approved photobiomodulation therapy (PBMT) as a treatment for breast cancer-related arm lymphedema (BCRL) in 2006. The investigators conducted two pilot clinical trials. Results demonstrated the feasibility, acceptability, and preliminary efficacy of PBMT for the treatment of chronic lymphedema in head and neck cancer (HNC) survivors. The objective of this study is to further investigate and confirm the positive effects of PBMT on HNC-related chronic lymphedema.

WITHDRAWN
Lymphedema Treatment in Head and Neck Cancer Patients
Description

The purpose of this research is to evaluate the result of treatment for neck lymphedema on throat pressure in patients who have received radiation therapy for head and neck cancer.

COMPLETED
Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Description

This randomized pilot clinical trial studies how well the self-care program works in head and neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care activities for managing chronic swelling and tough/tight tissues in the head and neck region.

COMPLETED
Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Description

This research trial studies skin/soft tissue elasticity in head and neck cancer survivors with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck cancer which may lead to skin tightness, pain, and body image issues. Early detection of lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave elastography is a technique that provides a quantitative measure of stiffness using a push pulse to generate shear waves within the tissues. Conventional imaging techniques are then used to monitor the shear waves generated through the tissue to calculate the shear wave speed. Shear wave elastography may help obtain an early and accurate measurement of tissue elasticity in head and neck cancer survivors.

Conditions
COMPLETED
The Fibrosis-Lymphedema Continuum in Head and Neck Cancer
Description

Goal: The primary goal of this study is to longitudinally investigate, in head and neck cancer (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine the development, patterns, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential biological correlatives including pro-inflammatory cytokines and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or lymphedema and select psychosocial stressors that potentially interact with cytokine pathways. H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or lymphedema. H: We will be able to differentiate characteristics patterns of the development of late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of inflammatory response and the development of late-effect fibrosis and/or lymphedema. H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis and/or lymphedema. H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total dose of radiation to involved anatomical site. H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and social withdrawal than those without these conditions.

RECRUITING
Head and Neck Cancer Patient Symptom and Oncologic Outcomes
Description

This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.

NOT_YET_RECRUITING
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients
Description

Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact. This is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.

TERMINATED
Home-Based Lymphedema Care Program (HBLCP) in Improving Lymphedema Self-Care in Head and Neck Cancer Survivors
Description

This pilot clinical trial studies a home-based lymphedema care program in improving lymphedema self-care in head and neck cancer survivors. A home-based lymphedema care program may help head and neck cancer survivors manage their lymphedema and improve their well-being and quality of life.

COMPLETED
Developing a Checklist of Lymphedema Symptoms in Patients With Head and Neck Cancer
Description

RATIONALE: Developing a symptom checklist for late-effect lymphedema may help doctors learn more about lymphedema in patients with head and neck cancer and plan the best treatment. PURPOSE: This phase I/II trial is developing a checklist of lymphedema symptoms in patients with head and neck cancer.

COMPLETED
Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer
Description

RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer may help doctors learn more about the disease and plan the best treatment. PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.

NOT_YET_RECRUITING
Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
Description

To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.