Fatigue Caused by Chemotherapy in Women Who Have Undergone Surgery for Breast Cancer and in Healthy Volunteers
NCT ID: NCT00909662
Last Updated: 2015-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
18 participants
OBSERVATIONAL
2008-07-31
2010-12-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients
Female patients with operable breast cancer intending to undergo adjuvant chemotherapy
assessment of therapy complications
1. Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
2. Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
3. Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
4. Borg 15-Category Scale
cognitive assessment
Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
fatigue assessment and management
1. Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
2. Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
3. Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
4. Borg 15-Category Scale
Participants
Female control subjects will be recruited, consisting predominantly of age-matched (i.e.+/- 10 years of age) friends or family members of the patients.
assessment of therapy complications
1. Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
2. Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
3. Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
4. Borg 15-Category Scale
cognitive assessment
Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
fatigue assessment and management
1. Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
2. Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
3. Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
4. Borg 15-Category Scale
Interventions
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assessment of therapy complications
1. Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
2. Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
3. Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
4. Borg 15-Category Scale
cognitive assessment
Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
fatigue assessment and management
1. Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen
2. Cognitive Task (2 timed 2-minute tests) with Concomitant EEG
3. Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS
4. Borg 15-Category Scale
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Halle Moore, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Joseph Baar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE7107
Identifier Type: OTHER
Identifier Source: secondary_id
CASE-7107-CC400
Identifier Type: OTHER
Identifier Source: secondary_id
CASE7107
Identifier Type: -
Identifier Source: org_study_id
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