Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer

Completed

• Conditions: Breast Cancer; Radiation Toxicity; Pain; Psychosocial Deprivation; Fatigue; Skin Abnormalities; Cognitive Ability, General

• Registration Number: NCT01407770
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy may cause skin reactions when patients are exposed to high-energy x rays. Studying the genetic pattern of patients before and after radiation therapy may help doctors prevent toxicity and plan the best treatment.

PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin reactions in racial/ethnic groups of patients with breast cancer.

Detailed Description

OBJECTIVES:

* To develop and validate prediction biomarkers for radiation therapy (RT)-induced acute and chronic skin reactions and quality of life in five racial/ethnic groups of breast cancer patients, Whites\*, Black/African Americans, Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and American Indians/Alaskan Natives. NOTE: \*This stratum is closed as of April 25, 2012.

* To develop polygenic models of RT-induced skin reactions with a comprehensive evaluation of genome-wide nonsynonymous single nucleotide polymorphisms (nsSNPs).

* To evaluate the levels of DNA damage (Comet assay) and radiosensitivity (Cell Cycle G2 Delay assay) in lymphocytes before and after RT.

* To test the effect of gene-gene and gene-smoking interactions on RT-induced skin reactions.

* To assess race-ethnic differences in RT-induced skin reactions, DNA damage, and radiosensitivity and to determine if the gene effects are consistent across race-ethnicity (gene-race/ethnic interactions).

OUTLINE: This is a multicenter study. Patients are stratified according to race/ethnicity (Whites\* vs Black/African Americans vs Hispanic/Latinos vs Asians/Native Hawaiians/Pacific Islanders vs American Indians/Alaskan Natives). NOTE: \*This stratum is closed as of April 25, 2012.

Patients undergo adjuvant radiotherapy after breast-conserving surgery.

Blood and urine samples are collected at baseline and last day of radiotherapy for genotyping, DNA damage, cell cycle assays, urine cotinine, inflammatory immune response biomarkers, and tumor-killing activity by BeadArray System, Comet assay, flow cytometry-based assay, Cell-Cycle G2 Delay Assay, Oxygen Radical Absorbance Capacity (ORAC) assay, and ELISA.

Patients are assessed for acute toxicity by research staff using the ONS Criteria for Radiation-Induced Acute Skin Toxicity at baseline, week 3, and at 1 and 2 months after radiotherapy. Patients are also assessed for chronic toxicity by research staff using the Chronic skin toxicity questionnaire (RTOG SOMA Criteria for RT- Induced Breast/Chest Wall Late Skin Toxicity) at 6 and 12 months after completion of radiotherapy. Photographs of the breast, chest wall, and contralateral breast are also taken at baseline, week 3, last day of radiotherapy, and at 1, 2, 6, and 12 months after completion of radiotherapy.

Patients complete the Breast Cancer Risk Study Questionnaire, the Functional Assessment of Cancer Therapy Breast (FACT-B), the Modified Skindex, and the B39 Quality-of-Life (QOL) Questionnaire at baseline, last day of radiotherapy, and at 1, 2, 6, and 12 months after radiotherapy.

Study Timeline

• Study First Submitted: 2011-07-30
• Study First Submitted QC: 2011-07-30
• Study First Posted: 2011-08-02
• Study Start: 2011-09-20
• Primary Completion: 2014-08-26
• Study Completion: 2014-08-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of RT-induced early adverse skin reaction (EASR)	2 months	The primary endpoint is RT-related skin reactions which for consistency and clarity across the study we will use the term "Early Adverse Skin Reaction" (EASR). Skin reactions will be assessed at 4 time points from the start of radiotherapy through 2 months of the post radiotherapy follow-up period. The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. The primary outcome variable will be the occurrence (or not) of RT-induced EASR defined as a grade 4 or higher toxicity (based on the ONS criteria) during the 2 months of the follow-up period of the study.

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by FACT-B	12 months	Quality of life will be assessed using the FACT-B, a modification of the Skindex-16, and a modified version of the NSABP B39 Quality of Life metric.

Trial Locations

Locations (1)

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States