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.
OBJECTIVES: * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
7
A single infusion of 1mg/kg will be administered.
Medical, psychiatric, and immune evaluation.
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.
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
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
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Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.