Sponsor study identifier
Secondary identifiers
NIH
OTHER · Case Comprehensive Cancer Center
OTHER · Cancer Center IRB
observational
18
1 country
2
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 27, 2009
Actual (reported)May 28, 2009
Actual (reported)December 2010
Actual (reported)December 2010
Actual (reported)Treatment-related fatigue as assessed by a brief fatigue inventory, a Brief Mental Fatigue Questionnaire, and a motor fatigability task with concurrent physiological measurements at baseline, during treatment, and 1 year after treatment completion
at baseline, after completion of 3-4 courses of standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment.
Cognitive function as assessed by the Wechsler Adult Intelligence Scale III at baseline, during treatment, and 1 year after treatment completion
at baseline, after completion of 3-4 courses of standard adjuvant chemotherapy, and 1-3 weeks after completion of the most recent treatment.
Recovery at 1 year
at 1 year
Female patients with operable breast cancer intending to undergo adjuvant chemotherapy
Female control subjects will be recruited, consisting predominantly of age-matched (i.e.+/- 10 years of age) friends or family members of the patients.
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 Task (2 timed 2-minute tests) with Concomitant EEG
Female patients with operable breast cancer intending to undergo adjuvant chemotherapy will be enrolled from the outpatient oncology clinics of the Case Comprehensive Cancer Center. Twenty female control subjects will be recruited, consisting predominantly of age-matched (i.e. +/- 10 years of age) friends or family members of the patients.
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
Halle Moore, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Joseph Baar, MD, PhD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
18 participants (actual enrollment reported by the registry).
First Submitted
May 27, 2009
First Posted
May 28, 2009
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Older Patients With Newly Diagnosed Breast Cancer or Colon Cancer
Quantification of brain and muscle signal alteration in patients and controls with and without treatment-related fatigue as assessed by high-density EEG or EMG and force
measurements at baseline, during treatment, and 1 year after treatment completion
Characterization of potential abnormal signal processing in the brain in patients experiencing chemotherapy-related cognitive dysfunction as evaluated by cognitive-assessment testing and high-density EEG
measurements at baseline, during treatment, and 1 year after treatment completion
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
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Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
October 2, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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