Status:
TERMINATED
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Breast Cancer
Fatigue
Eligibility:
FEMALE
45-65 years
Phase:
PHASE2
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-...
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....
Eligibility Criteria
Inclusion
- Women who report elevated fatigue following cancer diagnosis and treatment
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00112749
Start Date
February 1 2005
End Date
November 1 2012
Last Update
July 31 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781