Trial | NCT00112749  Report issue

Title

Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    infliximab ...

  • Study Participants

    7
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 Started
Feb 28
2005
Primary Completion
Jan 31
2007
Study Completion
Nov 30
2012
Last Update
Jul 31
2020

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.

Study Arm Experimental

Please see intervention description

Criteria 

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
No Results Posted