NCT05371795

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

April 26, 2022

Last Update Submit

June 7, 2022

Conditions

RadiotherapyTattooing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • RTTs' satisfaction

    Day 1

  • Cosmesis

    one of the last three days of irradiation

Other Outcomes (1)

  • Tattoo fading

    6 months from the end of irradiation

Study Arms (2)

Lancets

ACTIVE COMPARATOR
Device: Lancets

Comfort Marker 2.0

EXPERIMENTAL
Device: Comfort Marker 2.0

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.

Comfort Marker 2.0
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.

Lancets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Português de Oncologia do Porto Francisco Genti

Porto, 4200-072, Portugal

Location

Related Publications (1)

  • Pires AM, Carvalho L, Santos AC, Vilaca AM, Coelho AR, Oliveira C, Costa C, Fernandes F, Moreira L, Lima J, Vieira R, Ferraz MJ, Silva M, Silva P, Matias R, Zorro S, Costa S, Sarandao S, Barros AF. Radiation Therapy Skin Marking with Lancets Versus Electric Marking Pen (COMFORTATTOO)-6 Months Results on Cosmesis, Fading, and Patients' Satisfaction From a Randomized, Double-Blind Trial. Adv Radiat Oncol. 2023 Nov 5;9(3):101404. doi: 10.1016/j.adro.2023.101404. eCollection 2024 Mar.

    PMID: 38292889DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 12, 2022

Study Start

October 18, 2021

Primary Completion

March 11, 2022

Study Completion

September 1, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)