Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
RATIONALE: Infliximab may help improve energy levels in patients who have undergone treatment for breast cancer.
PURPOSE: This phase II trial is studying how well infliximab works in treating cancer-related fatigue in postmenopausal women who have undergone treatment for stage 0, stage I, or stage II breast cancer.
Other: Clinical Assessment
Other: Self-report questionnaires
Other: Immune Assessment
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?|
- Change in fatigue as measured by the fatigue symptom inventory (FSI) [ Time Frame: At baseline and after completion of study treatment, 4 years ]
- Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI) [ Time Frame: At baseline and after completion of study treatment, 4 years ]
- Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value [ Time Frame: At baseline and after completion of study treatment, 4 years ]
- Change in proinflammatory cytokines as measured by interleukin 6 value [ Time Frame: At baseline and after completion of study treatment, 4 years ]
- Change in proinflammatory cytokines as measured by tumor necrosis factor [ Time Frame: At baseline and after completion of study treatment, 4 years ]
|Study Start Date:||February 2005|
|Study Completion Date:||November 2012|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Experimental: Study Arm
Please see intervention description
A single infusion of 1mg/kg will be administered.Other: Clinical Assessment
Medical, psychiatric, and immune evaluation.Other: Self-report questionnaires
Fatigue Symptom Inventory, Multidimensional Fatigue Symptom Inventory, Hamilton Depression Rating Scale, Beck Depression Inventory II, Hamilton anxiety Rating Scale, Pittsburgh Sleep Quality Index, Brief Pain Inventory, MOS SF-36.Other: Immune Assessment
Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.
- Determine the association between the body's immune system and energy, sleep, mood, and other symptoms in postmenopausal women who have undergone treatment for stage 0-II breast cancer.
- Determine whether treatment with infliximab affects energy and immune function in these patients.
OUTLINE: Patients receive infliximab IV over 2 hours.
Patients complete a diary twice daily for 14 days before and for 14 days after infliximab administration to assess fatigue and other symptoms, including mood, pain, and sleep.
After completion of study treatment, patients are followed at 2 weeks and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112749
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Patricia A. Ganz, MD||Jonsson Comprehensive Cancer Center|