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

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

Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®

Study Overview

• Status: Active, not recruiting
• Conditions: Radiotherapy; Tattooing
• Intervention / Treatment: Device: Lancets; Device: Comfort Marker 2.0

Detailed Description

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®)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto Francisco Genti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lancets	Device: Lancets; 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.
Experimental: Comfort Marker 2.0	Device: Comfort Marker 2.0; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tattoo fading	A photographic assessment is performed. Every set-up marking is individually photographed a. All photographs are scored by indepe6 months after completion of the RT. 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 fading).	6 months from the end of irradiation

Collaborators and Investigators

• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CONFORTATTOO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No