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

Instituto Portugues de Oncologia, Francisco Gentil, Porto100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

100

Conditions

Radiotherapy Tattooing

Interventions

Comfort Marker 2.0DEVICE

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.

LancetsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto Português de Oncologia do Porto Francisco Genti

Porto, Portugal

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: up to 7 weeks

Secondary Outcomes

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).

Time frame: 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).

Time frame: one of the last three days of irradiation

Data from ClinicalTrials.gov

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