Fatigue Caused by Chemotherapy in Women Who Have Undergone Surgery for Breast Cancer and in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00909662 |
Recruitment Status :
Terminated
(Funding unavailable)
First Posted : May 28, 2009
Last Update Posted : October 2, 2015
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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.
Condition or disease | Intervention/treatment |
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Breast Cancer Cognitive/Functional Effects Fatigue Long-term Effects Secondary to Cancer Therapy in Adults | Procedure: assessment of therapy complications Procedure: cognitive assessment Procedure: fatigue assessment and management |
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.
Study Type : | Observational |
Actual Enrollment : | 18 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Group/Cohort | Intervention/treatment |
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Patients
Female patients with operable breast cancer intending to undergo adjuvant chemotherapy
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Procedure: assessment of therapy complications
Procedure: cognitive assessment Cognitive Task (2 timed 2-minute tests) with Concomitant EEG Procedure: fatigue assessment and management
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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.
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Procedure: assessment of therapy complications
Procedure: cognitive assessment Cognitive Task (2 timed 2-minute tests) with Concomitant EEG Procedure: fatigue assessment and management
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- 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at 1 year ]
- 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 [ Time Frame: 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 [ Time Frame: measurements at baseline, during treatment, and 1 year after treatment completion ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.
DISEASE CHARACTERISTICS:
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Meets either of the following criteria:
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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)
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- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909662
United States, Ohio | |
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Halle Moore, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
Principal Investigator: | Joseph Baar, MD, PhD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
Responsible Party: | Case Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00909662 |
Other Study ID Numbers: |
CASE7107 P30CA043703 ( U.S. NIH Grant/Contract ) CASE7107 ( Other Identifier: Case Comprehensive Cancer Center ) CASE-7107-CC400 ( Other Identifier: Cancer Center IRB ) |
First Posted: | May 28, 2009 Key Record Dates |
Last Update Posted: | October 2, 2015 |
Last Verified: | October 2015 |
cognitive/functional effects long-term effects secondary to cancer therapy in adults fatigue stage I breast cancer |
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Breast Neoplasms Fatigue Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases |