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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced Pneumatic Compression | Experimental | Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home. |
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| Standard-of-Care | Active Comparator | Subjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema. |
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| No Dermal Backflow | Other | Subjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared fluorescence lymphatic imaging | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence/Severity of lymphedema | The incidence of lymphedema between the control and treated groups will be compared. | Enrollment |
| Incidence/Severity of lymphedema | The incidence of lymphedema between the control and treated groups will be compared. | 3 months |
| Incidence/Severity of lymphedema | The incidence of lymphedema between the control and treated groups will be compared. | 6 months |
| Incidence/Severity of lymphedema | The incidence of lymphedema between the control and treated groups will be compared. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in area of dermal lymphatic backflow | 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. | 3 months |
| Change in area of dermal lymphatic backflow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Rasmussen, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Results will be published in a scientific journal along with description of protocol. The complete data set includes large (GBs) sequences of images as well as protected health information (faces). Partial, redacted data sets may be sharable upon request.
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| advanced pneumatic compression therapy | Device | 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. |
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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. |
| 6 months |
| Change in area of dermal lymphatic backflow | 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. | 12 months |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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