Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

Conditions
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Breast Cancer, Fatigue

Intervention / Treatment
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* Biological: infliximab
* Other: Clinical Assessment
* Other: Self-report questionnaires
* Other: Immune Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>Please see intervention description | Biological: infliximab<br>* A single infusion of 1mg/kg will be administered.<br>Other: Clinical Assessment<br>* Medical, psychiatric, and immune evaluation.<br>Other: Self-report questionnaires<br>* 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.<br>Other: Immune Assessment<br>* Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, breast cancer in situ, fatigue