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Physiotherapy for Lymphedema in Head and Neck Cancer Survivors
Phase 1
Waitlist Available
Led By John Rasmussen, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess whether treating lymphatics in head and neck cancer survivors before diagnosis of lymphedema can prevent its development or progression.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the pneumatic compression device, skin irritation from shaving (for males), or reactions related to near-infrared imaging; however, specific side effects of these interventions are not detailed in the provided information.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence/Severity of lymphedema
Secondary study objectives
Change in area of dermal lymphatic backflow
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: No Dermal BackflowExperimental Treatment1 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 CompressionExperimental Treatment2 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-CareActive Control1 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.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
344,269 Total Patients Enrolled
John Rasmussen, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
11 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and have a recent negative pregnancy test.I agree to use birth control for a month after imaging tests.I can use the compression device at home every day for up to a year.I don't have high pressure in my brain or issues that prevent pressure on my neck veins.My cancer has spread to the skin of my face or neck.I currently have an infection in my face.I agree to use birth control for one month after each imaging session.I have slow heartbeats causing symptoms and don't have a pacemaker, or I've had a clot in my neck vein recently.I finished my radiation therapy between 4 weeks and 3 months ago.I have severe leg artery disease with pain, wounds, or gangrene.I had surgery and radiation for my head and neck cancer.I agree to shave my facial hair on days I have imaging tests.I recently had symptoms like a mini-stroke or temporary vision loss.I have a recent clot in my veins or lungs.I am 18 years old or older.I have skin irritation from radiation, or a recent surgery wound that hasn't healed.I have been diagnosed with carotid sinus hypersensitivity.My chest circumference is 150 cm or more.I have severe heart failure.My thyroid or parathyroid condition is not under control, and I've been advised against pressure on my neck.I do not have any active skin infections or untreated skin inflammations.
Research Study Groups:
This trial has the following groups:- Group 1: No Dermal Backflow
- Group 2: Advanced Pneumatic Compression
- Group 3: Standard-of-Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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