Physiotherapy for Lymphedema in Head and Neck Cancer Survivors

Overseen By CJ Velasquez

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pregnancy, Iodine allergy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether early treatment can prevent lymphedema (swelling due to fluid buildup) in individuals who have had head and neck cancer. It examines the use of advanced pneumatic compression therapy, a device that helps move fluid, to determine if it can prevent lymphedema before symptoms appear. Participants will either use this therapy at home daily or receive standard care if lymphedema develops. The trial is suitable for those who have had head and neck cancer, completed radiation therapy between four weeks and three months ago, and can independently use the therapy device at home. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that advanced pneumatic compression therapy is safe for head and neck cancer survivors?

Studies have shown that advanced pneumatic compression therapy is safe for treating lymphedema in individuals who have had head and neck cancer. In earlier research, patients tolerated this treatment well and did not report any serious side effects while using the device at home. This therapy has also been tested on other body parts, such as the legs, and proved safe and effective there as well. Overall, existing evidence suggests that advanced pneumatic compression is a safe option for managing lymphedema. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about advanced pneumatic compression therapy for lymphedema in head and neck cancer survivors because it offers a promising alternative to traditional care. Unlike standard treatments that mainly involve manual lymphatic drainage and compression garments, this therapy uses a high-tech device to deliver precise, consistent pressure to affected areas, enhancing lymphatic flow and reducing swelling. The ease of home use empowers patients to manage their condition daily, potentially improving their quality of life and reducing the need for frequent hospital visits. This combination of convenience and effectiveness is what sets it apart from existing options.

What evidence suggests that advanced pneumatic compression therapy might be an effective treatment for preventing head and neck lymphedema?

Studies have shown that advanced pneumatic compression therapy, one of the treatments tested in this trial, can effectively reduce swelling in patients with lymphedema, especially those untreated. Research indicates that this treatment is safe, easy to use, and generally well-tolerated. In one study, participants noticed a reduction in swelling after just one session. This therapy gently massages the lymphatic system to help move fluid away from swollen areas. Early results from these studies are promising, suggesting that this approach could help manage lymphedema in head and neck cancer survivors. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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.

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5765451/

Usability of advanced pneumatic compression to treat cancer ... Results found the treatment to be safe, easy to use, and well tolerated while demonstrating edema reduction after a single initial treatment. Keywords: head and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05512767

A Pneumatic Compression Device for the Treatment of ... This clinical trial tests whether adding the use of a pneumatic compression system with manual lymphatic drainage versus manual lymphatic drainage alone in ...

3. iro.uiowa.edu iro.uiowa.edu/esploro/outputs/abstract/A-multisite-randomized-trial-of-an/9984966742002771

A multisite randomized trial of an advanced pneumatic ... Conclusions: We demonstrated that APCD therapy is an effective treatment modality in lymphedema therapy naïve HNCS. Furthermore, participants experienced ...

4. link.springer.com link.springer.com/article/10.1007/s00520-023-07698-3

Under recognition and treatment of lymphedema in head ... This study seeks to determine the incidence of HNC-related lymphedema diagnosis and treatment in a large US healthcare claims repository database.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7767900/

Advanced pneumatic compression for treatment of ... This trial supports the safety and feasibility of the APCD for the treatment of secondary lymphedema in head and neck cancer patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04797390

A Study Evaluating an Advanced Pneumatic Compression ... A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema. ClinicalTrials.gov ID NCT04797390.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X24003615

Results from a comparative study to evaluate the treatment ... Objective. Advanced pneumatic compression devices (APCDs) have been shown to be effective in treatment of lower extremity lymphedema in the home setting.

8. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/pneumatic-compression-devices.pdf

Pneumatic Compression Devices The authors note that this trial supports the safety and feasibility of the APCD for the treatment of secondary lymphedema in HNC patients. In addition, initial ...

9. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/medical-policies/Compression-Pumps-TX-Lymphedema.pdf

Medical Policy For individuals with lymphedema who failed to respond to conservative therapy, use of pneumatic compression pumps applied to the head or neck ...