20 Participants Needed

Physiotherapy for Lymphedema in Head and Neck Cancer Survivors

JR
CV
Overseen ByCJ Velasquez
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

JR

John Rasmussen, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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.
See 3 more

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.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo daily sessions of pneumatic compression therapy at home or receive standard-of-care treatment after clinical diagnosis of lymphedema

12 months
Daily sessions (home-based) for treated group; regular monitoring for control group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Advanced pneumatic compression therapy
  • Near-infrared fluorescence lymphatic imaging
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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: No Dermal BackflowExperimental Treatment1 Intervention
Group II: Advanced Pneumatic CompressionExperimental Treatment2 Interventions
Group III: Standard-of-CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

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Recruited
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