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Fatigue Assessment in Patients with Breast Cancer Undergoing Chemotherapy, Surgery, or Radiation Therapy


Active: Yes
Cancer Type: Breast Cancer
Unknown Primary
NCT ID: NCT02759549
Trial Phases: Protocol IDs: WCI1651-09 (primary)
NCI-2016-00824
IRB00028295
Eligibility: 0 Years and older, Female Study Type: Supportive care
Study Sponsor: Emory University Hospital/Winship Cancer Institute
NCI Full Details: http://clinicaltrials.gov/show/NCT02759549

Summary

This research trial studies the fatigue level in patients with breast cancer undergoing chemotherapy, surgery, or radiation therapy. Studying fatigue level in patients with breast cancer may help to improve the diagnosis and management of fatigue for future breast cancer patients receiving radiation.

Objectives

PRIMARY OBJECTIVES:
I. To determine longitudinal variances in inflammation, fatigue levels, and skin changes in breast cancer patients undergoing chemotherapy, surgery, and/or radiation (XRT).
II. To identify epigenetic changes related to breast cancer treatment and their relationship with treatment related inflammation, fatigue, and skin changes measured by ultrasound.
III. To determine the mechanisms by which breast cancer treatment induced epigenetic alterations that contribute to a persistent inflammatory state, fatigue, and treatment related skin changes.

OUTLINE:
Patients complete the questionnaire assessments during their cancer treatment for up to 9 assessments.

After completion of study, patients are followed up at 5-7 weeks, 5-7 months, and 12-18 months, or at 17 and 19 weeks, 7-10 months, and 15-18 months, and one time after 1 year.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.