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

Breast Cancer Clinical Trial

Official title:

Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00112749
• Other study ID #: CDR0000428460
• Secondary ID: UCLA-0410033-01
• Status: Terminated
• Phase: Phase 2
• Start date: February 2005
• Est. completion date: November 2012

Study information

• Verified date: February 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2012
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Biological:
• infliximab
A single infusion of 1mg/kg will be administered.

Other:
• Clinical Assessment
Medical, psychiatric, and immune evaluation.
• 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.
• Immune Assessment
Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue as measured by the fatigue symptom inventory (FSI)		At baseline and after completion of study treatment, 4 years
Primary	Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)		At baseline and after completion of study treatment, 4 years
Secondary	Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value		At baseline and after completion of study treatment, 4 years
Secondary	Change in proinflammatory cytokines as measured by interleukin 6 value		At baseline and after completion of study treatment, 4 years
Secondary	Change in proinflammatory cytokines as measured by tumor necrosis factor		At baseline and after completion of study treatment, 4 years