COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01407770
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : December 3, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Cancer Cognitive Ability, General Fatigue Pain Psychosocial Deprivation Radiation Toxicity Skin Abnormalities Genetic: DNA analysis Genetic: gene expression analysis Other: enzyme-linked immunosorbent assay Other: flow cytometry Other: laboratory biomarker analysis Other: questionnaire administration Procedure: adjuvant therapy Procedure: assessment of therapy complications Procedure: quality-of-life assessment Radiation: 3-dimensional conformal radiation therapy Radiation: breast irradiation Radiation: external beam radiation therapy Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy Radiation: whole breast irradiation

Detailed Description:


  • 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity
Study Start Date : September 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Other: enzyme-linked immunosorbent assay
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
  • Other: questionnaire administration
  • Procedure: adjuvant therapy
  • Procedure: assessment of therapy complications
  • Procedure: quality-of-life assessment
  • Radiation: 3-dimensional conformal radiation therapy
  • Radiation: breast irradiation
  • Radiation: external beam radiation therapy
  • Radiation: hypofractionated radiation therapy
  • Radiation: intensity-modulated radiation therapy
  • Radiation: whole breast irradiation

Primary Outcome Measures :
  1. Occurrence of RT-induced early adverse skin reaction (EASR) [ Time Frame: 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 :
  1. Quality of life as measured by FACT-B [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
blood and urine samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Race/ethnicity to include Whites*, Black/African Americans (AA), Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and Native American or Alaskan


  • Female patients newly diagnosed with breast carcinoma including ductal carcinoma in situ (DCIS)

    • Stage 0-IIIA disease
  • Status post-lumpectomy, -quadrantectomy, or -mastectomy
  • Plan to receive adjuvant radiation to the whole breast or chest wall and/or regional lymph nodes
  • No sites that cannot send blood/urine specimens to Wake Forest by overnight (next day) express shipping


  • *This stratum is closed as of April 25, 2012.
  • No patients who do not understand English and are unable to complete form with assistance


  • Total dose > 40 Gy, dose per fraction > 1.8 - 2.0 Gy, use of 2D, 3D-conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
  • Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
  • Adjuvant hormonal therapy will be allowed prior to, during, and/or after radiotherapy (RT) at the discretion of a medical oncologist
  • Targeted therapies, such as Herceptin, will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
  • No prior radiation to the involved breast or chest wall
  • No concurrent chemotherapy
  • No patients who underwent breast reconstruction following mastectomy

    • Placement of tissue expanders and implants are not allowed
  • No patients who have undergone MammoSite® or any other form of brachytherapy as well as those who will be treated with skin-sparing IMRT
  • Patients may not be concurrently enrolled in a protocol that involves treatment of the skin, i.e., applying lotions/moisturizers

    • Protocols that do not involve treatment of the skin are allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01407770

Layout table for location information
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: James J. Urbanic, MD Wake Forest University Health Sciences
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences Identifier: NCT01407770    
Other Study ID Numbers: IRB00011809
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU97609 ( Other Identifier: NCI )
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
radiation toxicity
skin reactions secondary to radiation therapy
psychosocial effects of cancer and its treatment
cognitive/functional effects
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
ductal breast carcinoma in situ
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Skin Abnormalities
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms
Congenital Abnormalities