NCT05937269
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatmentThe University of Texas Health Science Center, HoustonInvestigator-initiated
~20 participants
Updated 2025-09-09 on ClinicalTrials.gov
What's tested:Near-infrared fluorescence lymphatic imagingadvanced pneumatic compression therapy
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence/Severity of lymphedema
Measured over Enrollment
+3 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- John Rasmussen, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Incidence/Severity of lymphedemaEnrollment
The incidence of lymphedema between the control and treated groups will be compared.
- Incidence/Severity of lymphedema3 months
The incidence of lymphedema between the control and treated groups will be compared.
- Incidence/Severity of lymphedema6 months
The incidence of lymphedema between the control and treated groups will be compared.
- Incidence/Severity of lymphedema12 months
The incidence of lymphedema between the control and treated groups will be compared.