NCT00112749

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

Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Fatigue

Interventions

Type	Name	Description
BIOLOGICAL	infliximab	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.

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-01-01
• Completion: 2012-11-01
• First posted: 2005-06-03
• Last updated: 2020-07-31

Locations

1 site across 1 country: United States