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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00909662
• Other study ID #: CASE7107
• Secondary ID: P30CA043703CASE7
• Status: Terminated
• Phase: N/A
• First received: May 27, 2009
• Last updated: October 1, 2015
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: October 2015
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	Recovery at 1 year		at 1 year	No
Primary	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	No
Primary	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	No