Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

State University of New York - Upstate Medical University

Status: Terminated

Conditions: Abnormalities, Radiation-Induced

Study type: Observational

Funder types: Other

Identifiers

NCT00652678

Project # 1050425

Details and patient eligibility

About

Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Full description

Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

Enrollment: 38 patients

Sex: Female

Ages: 48+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer treatment: lumpectomy followed by external beam XRT to breast
• Age at the time of radiotherapy treatment: 45-65 years old
• XRT dose to breast: >/= 4500 and </= 5200 cGy, fraction size 180 or 200 cGy
• Dose distribution: no area receiving >/= 112% of prescribed dose
• Follow-ups: patients must be >/= 2.5 years post-treatment

Exclusion criteria

• Reconstructive surgery to involved breast