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

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Status: Active, not recruiting

Conditions: Tattooing; Radiotherapy

Treatments: Device: Lancets; Device: Comfort Marker 2.0

Study type: Interventional

Funder types: Other

Identifiers

NCT05371795

CONFORTATTOO

Details and patient eligibility

About

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

Full 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®)

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Lancets

Active Comparator group

Treatment:

Device: Lancets

Comfort Marker 2.0

Experimental group

Treatment:

Device: Comfort Marker 2.0