Physiotherapy for Lymphedema in Head and Neck Cancer Survivors

Overseen by John Rasmussen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: The University of Texas Health Science Center, Houston

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Rasmussen, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults over 18 who've had head and neck cancer surgery and radiation, are within 3 months post-radiation but not pregnant or breastfeeding. They must agree to contraception use after imaging sessions, shave facial hair if male, and be able to use a compression device at home.

Inclusion Criteria

I am a woman who can have children and have a recent negative pregnancy test.

I can use the compression device at home every day for up to a year.

I agree to use birth control for one month after each imaging session.

Exclusion Criteria

Iodine allergy

Any condition where increased venous and lymphatic return is undesirable

I agree to use birth control for a month after imaging tests.

Treatment Details

Interventions

• Advanced pneumatic compression therapy (Procedure)
• Near-infrared fluorescence lymphatic imaging (Behavioural Intervention)

Trial Overview The study tests if early physiotherapy can prevent lymphedema in head and neck cancer survivors. It uses near-infrared imaging to detect abnormal lymph flow and compares pneumatic compression therapy against standard care in preventing lymphatic dysfunction.

Participant Groups

Group I: No Dermal Backflow Experimental Treatment 1 Intervention

Subjects who do not present with dermal lymphatic backflow at enrollment will be monitored at subsequent visits and if/when dermal lymphatic backflow is observed will be randomized into either Advanced Pneumatic Compression or Standard-of-Care arm.

Group II: Advanced Pneumatic Compression Experimental Treatment 2 Interventions

Subjects who present with dermal lymphatic backflow will be asked to complete a session of advanced pneumatic compression therapy each day at home.

Group III: Standard-of-Care Active Control 1 Intervention

Subjects who present with dermal lymphatic backflow will continue under standard-of-care surveillance of lymphedema and will only receive treatment if they are diagnosed with head and neck cancer-acquired lymphedema.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD