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

Breast Cancer Clinical Trial

Official title:

Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803516
• Other study ID #: 13-013
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: February 5, 2018
• Start date: February 2013
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation-Induced Telangiectasias
• Telangiectasis

Intervention

Behavioral:
• questionnaires
This study will be offered to patients who, at the time of consultation are identified as having had adjuvant breast radiation treatment following surgical treatment for breast cancer and developed radiation-induced telangiectasias. The Skindex-16 and BREAST-Q questionnaires will be used to evaluate the quality of life of The study participants. For each instrument, for each evaluation time point, QOL scores will be summed and transformed into a scale from 0-100. Descriptive statistics will be used to describe the QOL of the study participants.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate quality-of-life (QoL)	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center