Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
- Conditions
- Breast CancerFatigue
- Interventions
- Biological: infliximabOther: Clinical AssessmentOther: Self-report questionnairesOther: Immune Assessment
- Registration Number
- NCT00112749
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 7
- Women who report elevated fatigue following cancer diagnosis and treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Arm Clinical Assessment Please see intervention description Study Arm Self-report questionnaires Please see intervention description Study Arm Immune Assessment Please see intervention description Study Arm infliximab Please see intervention description
- Primary Outcome Measures
Name Time Method Change in fatigue as measured by the fatigue symptom inventory (FSI) At baseline and after completion of study treatment, 4 years Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI) At baseline and after completion of study treatment, 4 years
- Secondary Outcome Measures
Name Time Method Change in proinflammatory cytokines as measured by interleukin 6 value At baseline and after completion of study treatment, 4 years Change in proinflammatory cytokines as measured by tumor necrosis factor At baseline and after completion of study treatment, 4 years Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value At baseline and after completion of study treatment, 4 years
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States