Fatigue Caused by Chemotherapy in Women Who Have Undergone Surgery for Breast Cancer and in Healthy Volunteers



Status:Terminated
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cognitive Studies, Cognitive Studies, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2008
End Date:December 2010

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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.

DISEASE CHARACTERISTICS:

- Meets either of the following criteria:

- Has completed surgery for stage I-III breast cancer AND meets the following
criteria:

- No bilateral axillary dissection

- Clinically free of active disease

- Planning to receive adjuvant chemotherapy for operable breast cancer

- Friend or relative of patient matched for age (± 10 years) (control)

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Known menopausal status

- Able to read English

- No history of significant cardiovascular disease or stroke, polyneuropathy,
amyotrophy, myosthenic syndrome, or pulmonary compromise

- Prior depression allowed provided that it was not significant

- Willing to come to the Cleveland Clinic for 3 assessments

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-2273
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center We all know...
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