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
Calvary Mater Newcastle
10 participants
Mar 3, 2025
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
Inclusion Criteria4
- Capable of providing informed consent
- years or older
- Completed adjuvant or definitive radiotherapy for a head and neck cancer at least 3 months - prior to enrolment
- Visible (external HNL) and moderate grade mucosal lymphoedema at any subsite according to the Patterson Scale (internal HNL)
Exclusion Criteria5
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Head & Neck Lymphoedema greater than or equal to Grade 3 as per MD Anderson Scale
- Previous treatment for lymphoma including neck surgery or radiation
- Recurrent cancer
- Patients with coexisting medical conditions that preclude them from wearing the DP-Tx neck wrap (including but not limited to sensitivity to any component of the product, broken skin in the neck area e.g. dermatitis, chronic neck pain, cerebrovascular disease or evidence of severe carotid stenosis on staging CT scans, tracheostomy, laryngectomy)
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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 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)
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ACTRN12624001333505