RecruitingACTRN12624001333505

HANLOT Trial - Phase 1 Trial of a Differential Pressure Product for Treatment of Head and Neck Lymphoedema

Phase 1 Tolerability Trial of a Differential Pressure Product, the ChezLeon DP-Tx neck wrap, for Treatment of Head and Neck Lymphoedema in Patients who have completed Adjuvant or Definitive Radiotherapy for a Head and Neck Cancer


Sponsor

Calvary Mater Newcastle

Enrollment

10 participants

Start Date

Mar 3, 2025

Study Type

Interventional

Conditions

Summary

This study aims to assess the tolerability and efficacy of the ChezLeon DP-Tx product (neck wrap) for patients with head and neck lymphoedema (HNL) after radiotherapy. Who is it for? You may be eligible for this study if you are an adult patient who has completed adjuvant or definitive radiotherapy for a head and neck cancer, at least 3 months prior to enrolment into this study, and have visible and/or moderate grade external and internal lymphoedema. Study details Participants will be asked to wear the neck wrap as much as possible over a 6-week period and will be asked to provide feedback on tolerability of the neck wrap. HNL measurements will be taken at various timepoints to determine efficacy. It is hoped that findings from this study will help inform future clinical trials to develop this treatment device for head and neck lymphoedema after radiotherapy.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Head and neck lymphoedema is a swelling of the face, neck, and mouth area that commonly develops after radiation therapy for head and neck cancer. It can cause difficulty swallowing, changes to appearance, and significant discomfort. Current treatments for this type of lymphoedema are limited, and many patients struggle to manage the swelling effectively after treatment ends. This phase 1 study is testing a new wearable neck wrap device called ChezLeon DP-Tx, which uses differential pressure — gentle, targeted compression — to help reduce swelling in the head and neck area. Participants wear the wrap as much as possible over a 6-week period and provide feedback on how comfortable and easy it is to use. Swelling measurements are taken at several time points to assess whether the device reduces lymphoedema. You may be eligible if you are 18 or older, have completed radiotherapy for head and neck cancer at least 3 months ago, and have visible swelling and moderate internal lymphoedema. People with active or recurring cancer, a history of lymphoma, or medical conditions that prevent them from wearing a neck device (such as severe carotid artery disease or a tracheostomy) are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a non-randomised, single-arm phase 1 feasibility trial assessing the tolerability and efficacy of the ChezLeon DP-Tx product (neck wrap) in patients with head and neck lymphoedema (HNL) for at

This is a non-randomised, single-arm phase 1 feasibility trial assessing the tolerability and efficacy of the ChezLeon DP-Tx product (neck wrap) in patients with head and neck lymphoedema (HNL) for at least 3 months post radiotherapy. Participants will be asked to wear the DP- Tx neck wrap as much as possible over for 6 weeks. Participants will be shown how to fit the neck wrap at their first trial visit and also provided with written instructions. The neck wrap is to be fitted firmly but comfortably around the neck and held in place by a Velcro fastening. Participants will be asked to provide feedback in a participant dairy on the comfort/tolerability of the neck wrap and how long it was worn each day and night of the 6-week trial. Participants will be asked to attend trial follow up visits at 1, 3 and 6-weeks. At each visit, participants will be asked about their experience wearing the neck wrap and participant diaries will be reviewed. HNL will also be assessed at Baseline, Week 3 & 6. External lymphedema. Head and neck measurements will be taken to assess changes in external lymphedema and a nasoendoscopy performed to assess changes internal lymphedema changes. A nasoendoscopy is a low-risk procedure that takes approximately 5 minutes to perform in which a small flexible camera is passed through the nose so that a clear view of your throat and surrounding structures can be obtained.


Locations(1)

Calvary Mater Newcastle - Waratah

NSW, Australia

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ACTRN12624001333505