Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-01 @ 7:39 PM
Study NCT ID:
NCT05937269
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-09
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck Cancer Survivorship
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
Assessing Impact of Early Physiotherapy on Lymphatic Dysfunction in Head and Neck
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: