Breast Cancer, Fatigue
Conditions
Keywords
stage I breast cancer, stage II breast cancer, breast cancer in situ, fatigue
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALinfliximab
A single infusion of 1mg/kg will be administered.
OTHERClinical Assessment
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.
OTHERImmune Assessment
Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.
Sponsors
American Cancer Society, Inc.
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Women who report elevated fatigue following cancer diagnosis and treatment
Exclusion criteria
* Women who have medical conditions that may affect the immune system or are associated with baseline fatigue syndrome, and/or who use medications that affect the immune system or fatigue. * Women with major affective disorders and those with sleep or pain disorders. * Presence of medical conditions that may but subject at undue risk for experimental procedures. * Chronic or recurring infections, symptoms of chronic heart failure, demyelinating disorders, and those taking immunosuppressive medications. * Neoplastic disease other than primary breast cancer * Compromised cardiovascular function * Insulin-dependent diabetes * Neurological disorder * Peripheral neuropathy * Pregnancy * Use of psychotropic medications within 2 weeks of screening * Abnormal screening laboratory findings (i.e., creatinine \> 1.4mg%; anemia; abnormal thyroid hormone; hematuria; elevated liver function tests, low protein or albumin; fasting glucose \>120mg%; elevated FTI or TSH; positive TB screening, HIV screening or hepatitis C). * Smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fatigue as measured by the fatigue symptom inventory (FSI) | At baseline and after completion of study treatment, 4 years |
| Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI) | At baseline and after completion of study treatment, 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value | At baseline and after completion of study treatment, 4 years |
| Change in proinflammatory cytokines as measured by interleukin 6 value | At baseline and after completion of study treatment, 4 years |
| Change in proinflammatory cytokines as measured by tumor necrosis factor | At baseline and after completion of study treatment, 4 years |
Countries
United States
Outcome results
None listed