Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos

NCT03131011 | Terminated

• 1 other identifier: RRIC 2017-011
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.

Conditions

Breast Cancer Female; Body Image Disturbance

Outcome Measures

Primary Outcomes (1)

• Change in Body-image scale score

  Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.

  Day 0, Week 3, Week 12

Secondary Outcomes (4)

• Set-up Accuracy

  Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)

• Resource Requirements (Tattooing procedure length)

  Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)

• Resource Requirements (Treatment set-up procedure length)

  Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)

• Radiation Therapist Evaluation Survey of UV Tattoo Method

  Week 13

Study Arms (2)

Arm 1 - UV ink

EXPERIMENTAL

Radiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight.

Other: UV fluorescent ink

Arm 2 - Black ink

NO INTERVENTION

Radiotherapy tattoos will be applied using standard black ink.

Interventions

UV fluorescent ink OTHER

The use of UV tattoo ink results in a tattoo that is visible only under an ultraviolet light. Conventional black tattoo ink is replaced with UV ink for the application of radiotherapy "dot" tattoos. Handheld UV flashlights are used to make the tattoos visible for use during radiotherapy treatment set-up.

Arm 1 - UV ink

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female age 18-60.
• Histologically confirmed early stage invasive ductal or lobular carcinoma of a single breast (T1N0M0-T2N0M0) or DCIS/LCIS (TisNxMx or TisN0M0) of a single breast.
• Deemed fit to undergo adjuvant radiotherapy to their breast by their supervising radiation oncologist.
• Able to provide written informed consent.
• Must be willing to be contacted by e-mail and have a valid e-mail account to complete follow up self-reported body image scale questionnaires.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Intact skin at site of standard radiotherapy tattoos. Must have access to a computer and be able and willing to comply with requirements of the protocol.

You may not qualify if:

• History of any prior radiotherapy courses to the chest or abdomen.
• Metastatic disease.
• Node positive breast cancer.
• Bilateral breast cancer or bilateral DCIS/LCIS.
• Deep-inspiration breath hold radiotherapy technique.
• Unable or unwilling to comply with the requirements of the protocol as assessed by the study investigator or coordinator.

Sponsors & Collaborators

• CancerCare Manitoba: lead

Study Sites (1)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Study Officials

• Julian Kim, MD, MSc

  CancerCare Manitoba

  PRINCIPAL INVESTIGATOR

• Erin V Toews, B.Sc., RTT

  CancerCare Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 27, 2017
• Study Start: September 10, 2017
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: June 13, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)