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Completed

NCT Number: NCT01803516

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Neoplasms Neoplasms by Site Radiation-Induced Telangiectasias Skin Diseases Skin and Connective Tissue Diseases Telangiectasis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

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.

Primary outcomes

  1. evaluate quality-of-life (QoL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2013
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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