QOL Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser

Completed

• Conditions: Breast Cancer; Radiation-Induced Telangiectasias
• Interventions: Behavioral: questionnaires

• Registration Number: NCT01803516
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to see how the look of telangiectasias (small dilated blood vessels) on radiated breast skin when altered by the pulsed dye laser affects a patient's overall well being.

Patients will have a set of treatments with a pulsed dye laser. This is a laser that targets red blood vessels and delivers heat causing the telangiectasias to become smaller and less visible. The laser has been used safely to treat telangiectasias on the skin of patients who received radiation for breast cancer.

Patients in the study will be asked to complete a questionnaire asking how they feel about the telangiectasias, their radiated skin and its effect on their daily lives. The questionnaire will be given at every visit. The improvement in the look of patients' radiated skin will also be compared to answers to the questionnaire. We hope the study will improve our understanding of how patients feel about the long term effects of radiation on their skin.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Locally advanced breast cancer patients treated with surgery and adjuvant radiation
• Telangiectasias in the radiation field of the treated breast
• Patients 18 years or older

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Exclusion Criteria

• Non English speaking
• Current oral steroid use or receiving daily therapeutic anticoagulation (e.g. Coumadin, Lovenox)
• Breast/s reconstructed with implant in the area of previous radiation
• Pregnancy or lactation
• Previous laser treatment of telangiectasias
• Presence of a sun tan in the area
• Fitzpatrick skin types V, VI

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer survivors with radiation-induced Telangiectasias	questionnaires	A quality of life assessment will also be completed by the patient using the Skindex-16 and a subscale of the BREAST-Q Breast Conserving Module questionnaire.

Primary Outcome Measures

Name	Time	Method
evaluate quality-of-life (QoL)	2 years	in breast cancer survivors with chronic radiation-induced telangiectasias who are undergoing pulsed dye laser treatment. To assess quality of life in relation to the radiation-induced telangiectasias, two pre-existing validated scales will be utilized. The Skindex-16 and BREAST-Q are scales that have been validated to assess quality of life.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States