Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device

Study Overview
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Brief Summary
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Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®

Detailed Description
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A Prospective, unicentric, randomized, controlled, parallel, double-blinded, cohort study comparing radiotherapy skin set-up markings with lancets versus electric marking device (Comfort Marker 2.0® by CIVCO®)

Official Title
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Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)

Conditions
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Radiotherapy, Tattooing

Intervention / Treatment
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* Device: Comfort Marker 2.0
* Device: Lancets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years old. Patients referred to our department to receive external beam radiation therapy. Eastern Cooperative Oncology Group performance status of 0 to 1. Estimated fractionating schedule of at least 13 once-daily fractions. Written informed consent. Exclusion Criteria: Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lancets<br> | Device: Lancets<br>* The set-up markings are created during the simulation session, after the CT simulation is acquired. For the control group, patients' markings are tattooed using a 28-gauge disposable lancet and india ink. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified.<br>|
| Experimental: Comfort Marker 2.0<br> | Device: Comfort Marker 2.0<br>* The set-up markings are created during the simulation session, after the CT simulation is acquired. For the experimental group, patients' markings are tattooed using an electric marking device developed for set-up marking, the Comfort Marker 2.0® (CM), designed by CIVCO medical solutions, using the 0.2mm deep application depth and the brand-included black pigment. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' comfort | Comfort is verbally assessed on the 11-point numeric pain scale. As more than one reference point is tattooed, the patients are asked to give an overall score to the procedure. | Day 1 | 
| Effectiveness | Effectiveness is assessed by the RTT team that delivered the daily fractions. Skin markings are individually evaluated at several periods, specifically at the first fraction, then every 5 fractions, and one last time in the last fraction of RT. These evaluations are scored on a 4-point graded scale (corresponding to bad, reasonable, good, and excellent). | up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RTTs' satisfaction | The RTT that executed the tattooing is asked to score the ease of the process on a three-point scale (easy, medium, and hard). | Day 1 | 
| Cosmesis | A photographic assessment is performed. Every set-up marking is individually photographed on one of the last three days of treatment. All photographs are scored by independent observers (both physicians and RTTs) blind to patient identity and treatment allocation, on a five-point scale (corresponding from bad to excellent cosmesis). | one of the last three days of irradiation |