Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
Stopped early · Phase 2
Conditions studied: Breast Cancer, Fatigue
In brief
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.
Key facts
- Study ID
- NCT00112749
- Run by
- Jonsson Comprehensive Cancer Center
- People needed
- 7
- Starts
- 2005-02-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2020-07-31
Who can join
Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women who report elevated fatigue following cancer diagnosis and treatment
You may not qualify if…
- 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
Where it is running
- Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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