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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Cognitive/Functional Effects, Fatigue, Long-term Effects Secondary to Cancer Therapy in Adults

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome 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.

Safety Issue:

No

Principal Investigator

Halle Moore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE7107

NCT ID:

NCT00909662

Start Date:

July 2008

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Cognitive/Functional Effects
  • Fatigue
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • 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

Name

Location

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