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

Jonsson Comprehensive Cancer Center

Status and phase

Terminated

Phase 2

Conditions

Breast Cancer

Fatigue

Treatments

Other: Immune Assessment

Other: Clinical Assessment

Biological: infliximab

Other: Self-report questionnaires

Study type

Interventional

Funder types

Other

Identifiers

NCT00112749

CDR0000428460

UCLA-0410033-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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