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Trial registered on ANZCTR


Registration number
ACTRN12625000040460p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Preoperative Laser Depilation of Donor Site in Head and Neck Cancer Free Flap Reconstruction [LaDDoR]
Scientific title
Changes in Hair Density of the Free Flap Following Preoperative Laser Depilation of Donor Site in Head and Neck Cancer Free Flap Reconstruction [LaDDoR]
Secondary ID [1] 313472 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
LaDDoR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 335879 0
Free Flap Reconstruction 335880 0
Condition category
Condition code
Surgery 332465 332465 0 0
Surgical techniques
Cancer 332466 332466 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary objective is to compare changes in the hair density of the free flap at key points of reconstruction: preoperatively and postoperatively for intervention and control groups.

Interventions include:
Appointment 1: Approx. 3weeks preop
Eligibility screen and Informed consent
Hair density measurement. Hair density in your donor site will be measured by clipping the hair, placing a custom 3D printed “ruler” and taking the photographs which will take approximately 15 to 30 minutes.
Functional and health-related quality of life [HRQOL] Questionnaire. which will take approximately 10 – 15 minutes

Appointment 2 and 3:
Laser treatment session (intervention group). Participants in the intervention group will undergo laser depilatory treatment to their donor site at Contour clinics, a laser clinic external to Chris O’Brien Lifehouse (no out-of-pocket cost for participant for laser treatment). A depilation guide marking the specific areas for laser treatment will be created and distributed to the laser technician.

The first laser session will be completed within a week of signing the consent form (approximately 2.5 weeks before your surgery), and the second session will be completed at least 3 days prior to your surgery. The sessions will be roughly 2 weeks apart and this will allow adequate time for common acute effects, such as erythema and pain, to resolve.

Each laser session will take approximately 60 minutes.

A treatment questionnaire including adverse event assessment and a visual analogue pain scale assessing the tolerability of treatment will be completed by participants on the same day of the intervention (via online or paper form already provided to participants). This will take approximately 5 -10 minutes.

Follow up:
An inpatient assessment will be conducted day 5 (+/- 2 days) post-op to review flap in the recipient site and record post-operative complications.

Hair density measurements at the recipient site and review of the donor site at 4- and 12-week routine postoperative clinic. The HRQOL questionnaire will be repeated at 12-week routine postoperative clinic or will be emailed/mailed to a participant.

Other than the laser depilation to the donor site prior to surgery, patients will be treated as per the usual standard of care for head and neck cancer reconstruction.
Intervention code [1] 330045 0
Treatment: Other
Intervention code [2] 330046 0
Treatment: Surgery
Comparator / control treatment
Consenting participants in the control group will receive standard care without any modifications. The control group will not receive any hair removal treatment and will have a scheduled surgery without any further procedures.
Control group
Active

Outcomes
Primary outcome [1] 340004 0
Compare changes in the hair density of the free flap at key points of reconstruction: preoperatively and postoperatively for intervention and control groups
Timepoint [1] 340004 0
Baseline (1-3 weeks preoperatively); 4 weeks postop (primary timepoint); 12 weeks postop
Secondary outcome [1] 442276 0
Assess changes in patient reported health-related quality of life [HRQOL]
Timepoint [1] 442276 0
Baseline (1-3 weeks preoperatively) and 12 weeks postop
Secondary outcome [2] 443056 0
Determine if any adverse events are experienced from the laser treatment
Timepoint [2] 443056 0
2 x Laser session treatments. First (approx. 2.5 weeks pre-operatively) and Second (approx. 3 days pre-operatively).
Secondary outcome [3] 443548 0
Determine the pain experienced from the laser treatment
Timepoint [3] 443548 0
2 x Laser session treatments. First (approx. 2.5 weeks pre-operatively) and Second (approx. 3 days pre-operatively).

Eligibility
Key inclusion criteria
• Willingness to give informed consent
• Patient undergoing major resection of the head and neck cancer with free flap reconstruction using hair-bearing donor site
• At least 18 years old
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Refusal to participate in study
• Patient undergoing free flap reconstruction without hair-bearing cutaneous donor site
• Patient receiving post-operative radiotherapy
• Unable to complete follow up period of study
• History of photosensitivity, keloids, skin pigmentation disorder, seizure disorder triggered by light
• Use of systemic retinoids or light-sensitizing drugs in the previous 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
REDCap randomisation module with randomisation table generated by SAS software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised in a 1:1 allocation (intervention and control group)
Patients will be randomised until 30 patients are included in each group (60 in total)
This will be done using a computerised sequence generation via REDCap
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
3/02/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27367 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 43460 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 317908 0
Hospital
Name [1] 317908 0
Chris O'Brien Lifehouse
Country [1] 317908 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 320257 0
None
Name [1] 320257 0
Address [1] 320257 0
Country [1] 320257 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316598 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316598 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 316598 0
Australia
Date submitted for ethics approval [1] 316598 0
25/11/2024
Approval date [1] 316598 0
Ethics approval number [1] 316598 0

Summary
Brief summary
The purpose of this research is to determine the effectiveness of laser treatment on the leg or arm that will be used to reconstruct your mouth after a removal of cancer before the surgery in reducing hair density in the mouth, and to assess overall satisfaction, including comfort and oral hygiene post-surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years and older, have head and neck cancer and will undergo free flap reconstruction using hair-bearing donor site.

Study Details:
By participating in this study, you will be randomised to either the control group (no laser hair removal treatment) or the intervention group (laser hair removal treatment).

Following your surgery, an assessment will be conducted while you are still in hospital to review your healing of donor site/free flap as a standard of care. Hair density measurements and a review of the free flap will also be conducted at your routine post operative review at 4 weeks and 12 weeks post-op.

Functional and health-related quality of life [HRQOL] patient reported outcome data will be collected using the FACE-Q Head and Neck Module questionnaire at the first appointment and 12 weeks postop.

It is hoped that findings from this study will help clinicians and researchers understand the utility of pre-operative laser treatment in improving quality of life for those undergoing head and neck reconstruction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138366 0
Dr James Wykes
Address 138366 0
Chris O'Brien Lifehouse 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 138366 0
Australia
Phone 138366 0
+61 02 9822 5331
Fax 138366 0
Email 138366 0
[email protected]
Contact person for public queries
Name 138367 0
Masako Dunn
Address 138367 0
Chris O'Brien Lifehouse 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 138367 0
Australia
Phone 138367 0
+61 02 8514 0411
Fax 138367 0
Email 138367 0
[email protected]
Contact person for scientific queries
Name 138368 0
James Wykes
Address 138368 0
Chris O'Brien Lifehouse 119-143 Missenden Rd, Camperdown, NSW, 2050
Country 138368 0
Australia
Phone 138368 0
+61 02 9822 5331
Fax 138368 0
Email 138368 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.