Breast Cancer Clinical Trial

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

Summary

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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

18

Study ID:

NCT00909662

Recruitment Status:

Terminated

Sponsor:

Case Comprehensive Cancer Center

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There are 2 Locations for this study

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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

18

Study ID:

NCT00909662

Recruitment Status:

Terminated

Sponsor:


Case Comprehensive Cancer Center

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