Clinical trial NCT03131011: Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos
Official title: Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Female
Body Image Disturbance
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Breast cancer patients ages 18-60 who are planned for adjuvant radiotherapy and who meet all inclusion/exclusion criteria will be offered voluntary participation in this trial. Recruitment will be open for approximately 18 months; it is anticipated that 1-2 patients will be recruited per week until the planned sample size is met. Participants will be stratified into three groups depending on their self-reported baseline Body-image satisfaction (BIS) score and will then be randomly allocated to receive conventional dark ink or UV fluorescent tattoos using permutated block randomization (4 patients per block) to ensure balance of BIS baseline average between study arms.

The investigators focus is to improve the current tattooing technique for breast cancer patients by introducing an alternate method that takes the patient's psychological perceptions of tattooing into account while first and foremost, continuing to guarantee that the current standard of accuracy in treatment delivery is maintained or improved. The investigators goal of decreasing the psychological effect of permanent radiotherapy tattoos aligns with CancerCare Manitoba's mission to improve the outcomes and quality of life for Manitobans with cancer.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Body-image scale score
timeFrame: Day 0, Week 3, Week 12
Secondary outcomes:
measure: Set-up Accuracy
timeFrame: Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
measure: Resource Requirements (Tattooing procedure length)
timeFrame: Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
measure: Resource Requirements (Treatment set-up procedure length)
timeFrame: Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
measure: Radiation Therapist Evaluation Survey of UV Tattoo Method
timeFrame: Week 13
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
Study officials:
affiliation: CancerCare Manitoba
name: Julian Kim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: CancerCare Manitoba
name: Erin V Toews, B.Sc., RTT
role: PRINCIPAL_INVESTIGATOR
References: