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

Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Fatigue; Cognitive/Functional Effects; Long-term Effects Secondary to Cancer Therapy in Adults
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44106-5065
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Female patients with operable breast cancer intending to undergo adjuvant chemotherapy	Procedure: assessment of therapy complications; Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen; Cognitive Task (2 timed 2-minute tests) with Concomitant EEG; Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS; Borg 15-Category Scale; Procedure: cognitive assessment; Cognitive Task (2 timed 2-minute tests) with Concomitant EEG; Procedure: fatigue assessment and management; Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen; Cognitive Task (2 timed 2-minute tests) with Concomitant EEG; Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS; 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; Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen; Cognitive Task (2 timed 2-minute tests) with Concomitant EEG; Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS; Borg 15-Category Scale; Procedure: cognitive assessment; Cognitive Task (2 timed 2-minute tests) with Concomitant EEG; Procedure: fatigue assessment and management; Questionnaires: Brief Fatigue Inventory, Brief Mental Fatigue and BDI FastScreen; Cognitive Task (2 timed 2-minute tests) with Concomitant EEG; Physical Task (Sustained Elbow Flexion) with Concomitant EEG and EMG plus TMS; Borg 15-Category Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: May 27, 2009
• First Submitted That Met QC Criteria: May 27, 2009
• First Posted (ESTIMATE): May 28, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: stage IIIA breast cancer; stage IIIB breast cancer; fatigue; stage II breast cancer; stage IIIC breast cancer; stage I breast cancer; cognitive/functional effects; long-term effects secondary to cancer therapy in adults
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: CASE7107 (OTHER: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); CASE-7107-CC400 (OTHER: Cancer Center IRB)