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

NCT01407770 | Completed DMC

• 3 other identifiers: IRB00011809U10CA081851REBACCCWFU97609
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

radiation toxicity; skin reactions secondary to radiation therapy; pain; fatigue; psychosocial effects of cancer and its treatment; depression; cognitive/functional effects; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

• Occurrence of RT-induced early adverse skin reaction (EASR)

  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.

  2 months

Secondary Outcomes (1)

• Quality of life as measured by FACT-B

  12 months

Interventions

DNA analysis GENETIC

Genetic

gene expression analysis GENETIC

Genetic

enzyme-linked immunosorbent assay OTHER

Genetic

flow cytometry OTHER

Genetic

laboratory biomarker analysis OTHER

Genetic

questionnaire administration OTHER

Genetic

adjuvant therapy PROCEDURE

Genetic

assessment of therapy complications PROCEDURE

Genetic

quality-of-life assessment PROCEDURE

Genetic

3-dimensional conformal radiation therapy RADIATION

Genetic

breast irradiation RADIATION

Genetic

external beam radiation therapy RADIATION

Genetic

hypofractionated radiation therapy RADIATION

Genetic

intensity-modulated radiation therapy RADIATION

Genetic

whole breast irradiation RADIATION

Genetic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: * \*This stratum is closed as of April 25, 2012. * No patients who do not understand English and are unable to complete form with assistance PRIOR CONCURRENT THERAPY: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Related Publications (1)

• Hu JJ, Urbanic JJ, Case LD, Takita C, Wright JL, Brown DR, Langefeld CD, Lively MO, Mitchell SE, Thakrar A, Bryant D, Baglan K, Strasser J, Baez-Diaz L, Lesser GJ, Shaw EG. Association Between Inflammatory Biomarker C-Reactive Protein and Radiotherapy-Induced Early Adverse Skin Reactions in a Multiracial/Ethnic Breast Cancer Population. J Clin Oncol. 2018 Aug 20;36(24):2473-2482. doi: 10.1200/JCO.2017.77.1790. Epub 2018 Jul 10.

  PMID: 29989859 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine samples

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Pain; Radiation Injuries; Skin Abnormalities; Depression; Carcinoma, Intraductal, Noninfiltrating

Interventions

Gene Expression Profiling; Enzyme-Linked Immunosorbent Assay; Flow Cytometry; Chemotherapy, Adjuvant; Radiotherapy, Conformal; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Wounds and Injuries; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• James J. Urbanic, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2011
• First Posted: August 2, 2011
• Study Start: September 20, 2011
• Primary Completion: August 26, 2014
• Study Completion: August 26, 2014
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

US (1)