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Search / Trial NCT05937269

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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jun 29, 2023

Trial Information

Current as of July 09, 2025

Enrolling by invitation

Keywords

Indocyanine Green Imaging Head And Neck Cancer Acquired Lymphedema Near Infrared Fluorescence Lymphatic Imaging Advanced Pneumatic Compression Therapy

ClinConnect Summary

No description provided

Gender

ALL

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

About The University Of Texas Health Science Center, Houston

The University of Texas Health Science Center at Houston (UTHealth) is a leading academic institution dedicated to advancing health through education, research, and clinical practice. As a prominent sponsor of clinical trials, UTHealth leverages its extensive resources and expertise in biomedical research to facilitate innovative studies aimed at improving patient outcomes. The institution is committed to fostering a collaborative environment that promotes scientific discovery and the translation of research findings into effective healthcare solutions, all while adhering to the highest ethical standards and regulatory guidelines. With a multidisciplinary approach, UTHealth plays a critical role in addressing complex health challenges and enhancing the quality of life in diverse communities.

Locations

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

John Rasmussen, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported