Clinical trial NCT05937269: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: 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
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence/Severity of lymphedema
timeFrame: Enrollment
measure: Incidence/Severity of lymphedema
timeFrame: 3 months
measure: Incidence/Severity of lymphedema
timeFrame: 6 months
measure: Incidence/Severity of lymphedema
timeFrame: 12 months
Secondary outcomes:
measure: Change in area of dermal lymphatic backflow
timeFrame: 3 months
measure: Change in area of dermal lymphatic backflow
timeFrame: 6 months
measure: Change in area of dermal lymphatic backflow
timeFrame: 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: John Rasmussen, PhD
role: PRINCIPAL_INVESTIGATOR
References: