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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment
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

Detailed 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.

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients
Female patients with operable breast cancer intending to undergo adjuvant chemotherapy
 Procedure: 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

Procedure: cognitive assessment
Cognitive Task (2 timed 2-minute tests) with Concomitant EEG

Procedure: 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.
 Procedure: 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

Procedure: cognitive assessment
Cognitive Task (2 timed 2-minute tests) with Concomitant EEG

Procedure: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Recovery at 1 year [ Time Frame: at 1 year ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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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
Study Population

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.

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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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
More Information
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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
Keywords provided by Case Comprehensive Cancer Center:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Fatigue
Neoplasms by Site
 Neoplasms
Breast Diseases
Skin Diseases