Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00112749|
Recruitment Status : Terminated (Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.)
First Posted : June 3, 2005
Last Update Posted : February 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Fatigue||Biological: infliximab Other: Clinical Assessment Other: Self-report questionnaires Other: Immune Assessment||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?|
|Study Start Date :||February 2005|
|Primary Completion Date :||January 2007|
|Study Completion Date :||November 2012|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|