Fatigue Assessment in Patients with Breast Cancer Undergoing Chemotherapy, Surgery, or Radiation Therapy
Breast Cancer
Unknown Primary
0 Years and older, Female
WCI1651-09 (primary)
NCI-2016-00824
IRB00028295
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.
IV. To determine longitudinal variances in comorbidities in breast cancer patients undergoing surgery, XRT, and hormone therapy.
V. To identify polygenetic risk score (PRS) of treatment related toxicities including comorbid conditions in non-Hispanic black (NHB) and non-Hispanic white (NHW) women with breast cancer.
VI. To investigate the association between PRS of treatment-related toxicities and inflammatory responses to breast cancer treatment.
SECONDARY OBJECTIVES:
I. Characterize the gut microbial communities (fecal samples) in 50 women with high-risk breast cancer at the beginning of the first cycle of chemotherapy (T0, within 2 weeks of start of chemotherapy), at the completion of the last cycle of chemotherapy (T1), and at 3 months post chemotherapy (T2) as compared with 25 age, race, and body mass index matched breast cancer patients who do not receive chemotherapy using 16S ribosomal ribonucleic acid (rRNA) V3-V4 gene sequencing technology.
II. Examine the trajectory of subjective and objective cognitive impairments assessed by the subjective Patient-Reported Outcomes Measurement Information System (PROMIS)–Cognitive Function scale and the objective cognition testing in breast cancer women from T0 to T2.
III. Investigate associations between the gut microbiome and scores on subjective and objective cognitive assessments for women with breast cancer undergoing chemotherapy, adjusting for demographics (e.g., age, race), clinical variables (e.g., diet, chemotherapy type, tumor stage, and use of antibiotics), and psychoneurological symptoms (e.g., fatigue, anxiety, and depression).
OUTLINE:
Patients complete questionnaires, undergo breast ultrasound and collection of blood samples, and have their medical records reviewed on study. Patients may also undergo stool sample collection on study.
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 beyond1 year.
Eligibility
- Will include NHB (n=125) and NHW (n=125) women with newly diagnosed pT1/T2N0M0 HR+, HER2- low risk breast cancer (e.g., low 21-Gene Recurrence [i.e., oncotype] or 70-gene signature [i.e., Mammaprint] or other low genomic assay) presenting for treatment at Emory
- Eligible patients are those who receive breast conserving surgery (e.g., lumpectomy) and are prescribed radiation and hormone therapy
- Among patients with tumors tested with the 21-Gene Recurrence Score or Oncotype assay, premenopausal patients with scores =< 18 or postmenopausal patients with scores > 25 are eligible
- Patients must have pT1 or pT2, node negative breast cancer
- Patients with isolated tumor cells N0 (i+) are eligible but patients with N1mi, N2, and N3 disease are not eligible
Treatment Sites in Georgia
**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.