The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
NCT Number: NCT05937269
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Houston, Texas, 77030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All subjects will undergo lymphatic imaging at enrollment, 3, 6, and 12 months to assess the extent of dermal lymphatic backflow. Small amounts (0.1 mL) of a solution of indocyanine green (ICG) will be intradermally injected near the ear and along the jaw. Images of the lymphatics will be acquired by shining a dim light on the face and neck and acquiring the resulting fluorescent signal emanating from ICG-laden lymph. Images will be processed to calculate the area of the head and neck that show abnormal dermal lymphatic backflow.
Other names: indocyanine green imaging
The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy.
Time frame: Enrollment
The incidence of lymphedema between the control and treated groups will be compared.
Time frame: 3 months
The incidence of lymphedema between the control and treated groups will be compared.
Time frame: 6 months
The incidence of lymphedema between the control and treated groups will be compared.
Time frame: 12 months
The incidence of lymphedema between the control and treated groups will be compared.
Time frame: 3 months
The change (from enrollment) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.
Time frame: 6 months
The change (from 3 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.
Time frame: 12 months
The change (from 6 months) in the area of the head and neck that is covered by abnormal dermal lymphatic backflow as assessed using near-infrared fluorescence lymphatic imaging.
The University of Texas Health Science Center, Houston
Other
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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