Breast Cancer Clinical Trial
Official title:
Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer
RATIONALE: Gathering information over time from women undergoing chemotherapy for breast
cancer may help doctors learn more about mental and physical fatigue caused by treatment.
PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have
undergone surgery for stage I, stage II, or stage III breast cancer and in healthy
volunteers.
OBJECTIVES:
- To assess treatment-related fatigue, cognitive dysfunction, and recovery in women
undergoing adjuvant chemotherapy for stage I-III breast cancer as compared with a
patient-selected control population.
- To determine whether fatigue induced by sustained isometric contraction (SIC) is more
of central or peripheral (muscular) origin in patients with and without
treatment-related fatigue.
- To characterize changes from baseline in potential abnormal signal processing in the
brain while performing cognitive-assessment testing (CAT) in patients experiencing
chemotherapy-related cognitive dysfunction compared with the controls.
OUTLINE: Patients and participants undergo assessment of treatment-related fatigue and
cognitive dysfunction (i.e., mental fatigue) at baseline, after completion of 3-4 courses of
standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment.
Patient recovery will be assessed at approximately 1 year from baseline. Study assessments
will include a brief fatigue inventory, a cognitive assessment, and muscle fatigability
testing through a sustained isometric contraction. Additional assessments will include
quantification of brain and muscle signal alterations in patients with and without
treatment-related fatigue and cognitive-assessment testing in patients experiencing
chemotherapy-related cognitive dysfunction.
Patients and participants also undergo collection of data to obtain information on patient
age, body mass index, and menopausal status at baseline and at 1 year. Additional
information is collected on type of chemotherapy treatment and any hormonal or other
anticancer treatments administered throughout the course of the study. Cancer recurrences or
new cancer events are also recorded.
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Observational Model: Case Control, Time Perspective: Prospective
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