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

Primary Purpose

Lymphedema of Face, Head and Neck Cancer

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Near-infrared fluorescence lymphatic imaging
advanced pneumatic compression therapy
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema of Face focused on measuring indocyanine green imaging, head and neck cancer-acquired lymphedema, near-infrared fluorescence lymphatic imaging, advanced pneumatic compression therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must be 18 years of age or older Participants must have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session Male participants must agree to shave facial hair on imaging days Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel. Exclusion Criteria: Persons who are pregnant or breast-feeding Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session Persons who do not meet inclusion criteria Iodine allergy Persons with a chest circumference of 150 cm or more Uncontrolled hyperthyroidism or parathyroidism (for which an endocrinologist recommends against neck compression) Carotid sinus hypersensitivity syndrome Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke or amaurosis fugax (monocular visual ischemic symptoms or blindness) Symptomatic bradycardia in the absence of a pacemaker or internal jugular venous thrombosis (within 3 months) Increased intracranial pressure or other contraindication to internal or external jugular venous compression Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6 to 8-weeks post-operative Facial or head and neck dermal metastasis Acute facial infection (e.g., facial, or parotid gland abscess) Heart failure (acute pulmonary edema, decompensated acute heart failure) Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene) Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease) Any condition where increased venous and lymphatic return is undesirable

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Advanced Pneumatic Compression

Standard-of-Care

No Dermal Backflow

Arm Description

Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home.

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.

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.

Outcomes

Primary Outcome Measures

Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.
Incidence/Severity of lymphedema
The incidence of lymphedema between the control and treated groups will be compared.

Secondary Outcome Measures

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.
Change in area of dermal lymphatic backflow
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.
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.

Full Information

First Posted
June 22, 2023
Last Updated
October 20, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05937269
Brief Title
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Official Title
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Face, Head and Neck Cancer
Keywords
indocyanine green imaging, head and neck cancer-acquired lymphedema, near-infrared fluorescence lymphatic imaging, advanced pneumatic compression therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Pneumatic Compression
Arm Type
Experimental
Arm Description
Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home.
Arm Title
Standard-of-Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Dermal Backflow
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Near-infrared fluorescence lymphatic imaging
Other Intervention Name(s)
indocyanine green imaging
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
advanced pneumatic compression therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence/Severity of lymphedema
Description
The incidence of lymphedema between the control and treated groups will be compared.
Time Frame
Enrollment
Title
Incidence/Severity of lymphedema
Description
The incidence of lymphedema between the control and treated groups will be compared.
Time Frame
3 months
Title
Incidence/Severity of lymphedema
Description
The incidence of lymphedema between the control and treated groups will be compared.
Time Frame
6 months
Title
Incidence/Severity of lymphedema
Description
The incidence of lymphedema between the control and treated groups will be compared.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in area of dermal lymphatic backflow
Description
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
3 months
Title
Change in area of dermal lymphatic backflow
Description
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
6 months
Title
Change in area of dermal lymphatic backflow
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must be 18 years of age or older Participants must have previously been diagnosed with head and neck cancer and undergone surgery and radiation as part of their standard-of-care treatment plan Participants must be ≥ 4 weeks but less than 3 months post-radiation therapy at enrollment Female participants of childbearing potential must have a negative urine pregnancy test ≤ 36 hours prior to study drug administration Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month after each imaging session Male participants must agree to shave facial hair on imaging days Participants must be willing and able to independently use the pneumatic compression device at home daily for up to 12 months as directed by study personnel. Exclusion Criteria: Persons who are pregnant or breast-feeding Females of child-bearing potential, who do not agree to use an approved contraceptive for one month after each imaging session Persons who do not meet inclusion criteria Iodine allergy Persons with a chest circumference of 150 cm or more Uncontrolled hyperthyroidism or parathyroidism (for which an endocrinologist recommends against neck compression) Carotid sinus hypersensitivity syndrome Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke or amaurosis fugax (monocular visual ischemic symptoms or blindness) Symptomatic bradycardia in the absence of a pacemaker or internal jugular venous thrombosis (within 3 months) Increased intracranial pressure or other contraindication to internal or external jugular venous compression Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6 to 8-weeks post-operative Facial or head and neck dermal metastasis Acute facial infection (e.g., facial, or parotid gland abscess) Heart failure (acute pulmonary edema, decompensated acute heart failure) Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene) Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin, or untreated inflammatory skin disease) Any condition where increased venous and lymphatic return is undesirable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rasmussen, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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