Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
This study has been completed.
Sponsor:
University of California, Los Angeles
Collaborators:
American Cancer Society, Inc.
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00112749
First received: June 2, 2005
Last updated: November 5, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Fatigue |
Biological: infliximab Other: Clinical Assessment Other: Self-report questionnaires Other: Immune Assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue? |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Infliximab
U.S. FDA Resources
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Fatigue as measured by the fatigue symptom inventory (FSI) at baseline and after completion of study treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Fatigue as measured by multidimensional fatigue symptom inventory (MFSI) at baseline and after completion of study [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proinflammatory cytokines as measured by interleukin-1 receptor antagonist, interleukin 6, and tumor necrosis factor at baseline and after completion of study treatment [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | February 2005 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Study Arm
Please see intervention description
|
Biological: infliximab
A single infusion of 1mg/kg will be administered.
Other: Clinical Assessment
Medical, psychiatric, and immune evaluation.
Other: 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.
Other: Immune Assessment
Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.
|
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.
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112749
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
Sponsors and Collaborators
University of California, Los Angeles
American Cancer Society, Inc.
Investigators
| Principal Investigator: | Patricia A. Ganz, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Patricia A. Ganz, Jonsson Comprehensive Cancer Center at UCLA |
| ClinicalTrials.gov Identifier: | NCT00112749 History of Changes |
| Other Study ID Numbers: | CDR0000428460, P30CA016042, UCLA-0410033-01 |
| Study First Received: | June 2, 2005 |
| Last Updated: | November 5, 2010 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
stage I breast cancer stage II breast cancer breast cancer in situ fatigue |
Additional relevant MeSH terms:
|
Breast Neoplasms Fatigue Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Signs and Symptoms |
Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013