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

NCT ID: NCT05937269

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2026-02-28

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.

Conditions

Lymphedema of Face; Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Advanced Pneumatic Compression

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

Group Type: EXPERIMENTAL

Near-infrared fluorescence lymphatic imaging

Intervention Type: 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.

advanced pneumatic compression therapy

Intervention Type: 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.

Standard-of-Care

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.

Group Type: ACTIVE_COMPARATOR

Near-infrared fluorescence lymphatic imaging

Intervention Type: 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.

No Dermal Backflow

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.

Group Type: OTHER

Near-infrared fluorescence lymphatic imaging

Intervention Type: 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.

Interventions

Near-infrared fluorescence lymphatic imaging

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: COMBINATION_PRODUCT

advanced pneumatic compression therapy

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.

Intervention Type: DEVICE

Other Intervention Names

indocyanine green imaging

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.

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

John Rasmussen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-23-0268

Identifier Type: -

Identifier Source: org_study_id