NCT00909662

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-05-28
• Last updated: 2015-10-02

Locations

2 sites across 1 country: United States