NCT00909662

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

May 27, 2009

Last Update Submit

October 1, 2015

Conditions

Breast CancerCognitive/Functional EffectsFatigueLong-term Effects Secondary to Cancer Therapy in Adults

Keywords

cognitive/functional effectslong-term effects secondary to cancer therapy in adultsfatiguestage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Patients

Female patients with operable breast cancer intending to undergo adjuvant chemotherapy

Procedure: assessment of therapy complicationsProcedure: cognitive assessmentProcedure: fatigue assessment and management

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 complicationsProcedure: cognitive assessmentProcedure: fatigue assessment and management

Interventions

assessment of therapy complicationsPROCEDURE

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

ParticipantsPatients
cognitive assessmentPROCEDURE

Cognitive Task (2 timed 2-minute tests) with Concomitant EEG

ParticipantsPatients
fatigue assessment and managementPROCEDURE

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

ParticipantsPatients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

Mental Status and Dementia TestsTherapeutics

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2009

First Posted

May 28, 2009

Study Start

July 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 2, 2015

Record last verified: 2015-10

Locations

US(2)