drugset / Trial / NCT05937269

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

NCT05937269

Phase 1 Enrolling by invitation 20 enrolled The University of Texas Health Science Center, Houston
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-10-12
Primary completion
2026-02-28
Completion
2026-02-28

Drugs

EvaluationDrugModalityDoseRoute
Background Indocyanine Green Diagnostic / imaging agent 0.1 ml Other