Clinical trial · Observational
Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity
NCT01407770CI-TRIAL-00065082completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Ability, General | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Psychosocial Deprivation | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Skin Abnormalities | — | UNRESOLVED | — |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| breast irradiation | Radiation | — | UNRESOLVED |
| DNA analysis | Genetic | — | UNRESOLVED |
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of RT-induced early adverse skin reaction (EASR)
- timeFrame
- 2 months
- description
- 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 outcomes (1)
- measure
- Quality of life as measured by FACT-B
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDHu 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