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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Eligibility
0 Years and older, Female
Study Type
Supportive care
NCT ID
NCT02759549
Protocol IDs
WCI1651-09 (primary)
NCI-2016-00824
IRB00028295
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Eligibility

  1. Breast cancer patients seen at the Emory breast centers (Emory Clinic and Emory Midtown Hospital) who receive definitive treatment

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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.