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

This study has been terminated.
(Funding unavailable)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00909662
First received: May 27, 2009
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Recovery at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909662

Locations
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
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
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00909662     History of Changes
Other Study ID Numbers: CASE7107, P30CA043703, CASE7107, CASE-7107-CC400
Study First Received: May 27, 2009
Last Updated: December 3, 2012
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Fatigue
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014