Lymphedema Clinical Trial
Official title:
Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors
Verified date | February 2022 |
Source | Vanderbilt-Ingram Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 2021 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed cancer involving the head and neck - Completed all therapy - No evidence of cancer (NED) - Ability to understand English in order to complete questionnaires - Able to provide informed consent Exclusion Criteria: - Have medical record documentation of significant cognitive impairment that would preclude the ability to provide informed consent - Are unwilling to undergo the study assessment - Have recurrent and/or metastatic cancer |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt-Ingram Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Elasticity values | Descriptive statistics will be used to describe data from elasticity measure. Of particular interest will be the measures of central tendency and variability at the multiple sites. Sites with higher variability (coefficient of variation) that others may be indicative of less reliable assessment. | Within 2 weeks of initial study visit | |
Secondary | Strength of associations of tissue elasticity and current conventional methods | Correlation coefficients will be used to assess the strength of the associations of the elasticity values with the respective LEF grades (HN-LEF) for the respective sites. Those values will also be correlated with Vanderbilt Head and Neck Symptom Survey and HN-LSIDS symptom and Cervical Range of Motion scores. Due to the large number of correlations proposed in this study, effect sizes (strength of the associations) and clinically significant patterns will be of much greater importance than statistical significance. | Within 2 weeks of initial study visit |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05507346 -
A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema
|
N/A | |
Completed |
NCT06067880 -
Surgical Intervention and Lymphatic Diseases.
|
||
Active, not recruiting |
NCT04797390 -
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
|
N/A | |
Completed |
NCT06323200 -
Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
|
||
Completed |
NCT02506530 -
Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema
|
N/A | |
Completed |
NCT02253186 -
Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema
|
N/A | |
Terminated |
NCT02020837 -
A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
|
Early Phase 1 | |
Recruiting |
NCT01318785 -
Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications
|
Phase 2 | |
Enrolling by invitation |
NCT02375165 -
Biomarkers for the Detection of Lymphatic Insufficiency
|
||
Completed |
NCT00852930 -
Low Level Laser Treatment and Breast Cancer Related Lymphedema
|
Phase 4 | |
Completed |
NCT02308488 -
Study of Prone Accelerated Breast And Nodal IMRT
|
N/A | |
Completed |
NCT01112189 -
Use of Stem Cells in Lymphedema Post Mastectomy
|
Phase 1/Phase 2 | |
Completed |
NCT00743314 -
Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer
|
Early Phase 1 | |
Recruiting |
NCT06237907 -
Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
|
||
Terminated |
NCT01580800 -
National Breast Cancer and Lymphedema Registry
|
||
Suspended |
NCT05366699 -
LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy
|
N/A | |
Completed |
NCT06249360 -
Lymphatic System Reflux After Lymphatic Operation
|
||
Completed |
NCT06220903 -
The Effect of Complex Decongestive Therapy in Patients With Lymphedema
|
N/A | |
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT06041958 -
Effects of Extracorporeal Shock Wave Therapy and Pulse Electromagnetic Field Therapy on Lymphoedema
|
N/A |