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Trial registered on ANZCTR


Registration number
ACTRN12624001333505
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
4/11/2024
Date last updated
4/11/2024
Date data sharing statement initially provided
4/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
HANLOT Trial - Phase 1 Trial of a Differential Pressure Product for Treatment of Head and Neck Lymphoedema
Scientific title
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
Secondary ID [1] 313067 0
CMNDRO-2401
Universal Trial Number (UTN)
Trial acronym
HANLOT Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Lymphoedema after radiotherapy 335296 0
Condition category
Condition code
Cancer 331871 331871 0 0
Head and neck
Cardiovascular 332140 332140 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329617 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339483 0
To assess the tolerability of the product, specifically participants being able to tolerate wearing the neck wrap for 2 or more hours per day.
Timepoint [1] 339483 0
Participants will keep a daily diary reporting on comfort/tolerability of the neck wrap and how long it was worn each day & night for the duration of the 6-week trial.
Secondary outcome [1] 440168 0
To assess changes in external HNL
Timepoint [1] 440168 0
ALOHA measurements will be performed at Baseline, 3- and 6-weeks post commencement of intervention
Secondary outcome [2] 441001 0
To assess changes in internal HNL
Timepoint [2] 441001 0
A nasoendoscopy will be performed to allow for Patterson scale assessments at Baseline, 3- and 6-weeks post commencement of intervention

Eligibility
Key inclusion criteria
Capable of providing informed consent
18 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
12/01/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27150 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 43230 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 317509 0
Hospital
Name [1] 317509 0
Calvary Mater Newcastle
Country [1] 317509 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Country
Australia
Secondary sponsor category [1] 319806 0
None
Name [1] 319806 0
Address [1] 319806 0
Country [1] 319806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316221 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316221 0
https://www.hnehealth.nsw.gov.au/research-office/research_ethics
Ethics committee country [1] 316221 0
Australia
Date submitted for ethics approval [1] 316221 0
24/09/2024
Approval date [1] 316221 0
16/10/2024
Ethics approval number [1] 316221 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51030 0
Dr Chris Wratten
Address 51030 0
Radiation Oncology, Calvary Mater Newcastle, Locked Bag 7 HRMC NSW 2310
Country 51030 0
Australia
Phone 51030 0
+61 2 4014 3633
Fax 51030 0
Email 51030 0
[email protected]
Contact person for public queries
Name 51031 0
Melissa Vassallo
Address 51031 0
Radiation Oncology, Calvary Mater Newcastle, Locked Bag 7 HRMC NSW 2310
Country 51031 0
Australia
Phone 51031 0
+61 2 4014 3944
Fax 51031 0
Email 51031 0
[email protected]
Contact person for scientific queries
Name 51032 0
Chris Wratten
Address 51032 0
Radiation Oncology, Calvary Mater Newcastle, Locked Bag 7 HRMC NSW 2310
Country 51032 0
Australia
Phone 51032 0
+61 2 4014 3633
Fax 51032 0
Email 51032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.