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

This study has been terminated.
(Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
American Cancer Society, Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00112749
First received: June 2, 2005
Last updated: February 12, 2016
Last verified: February 2016
  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:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in fatigue as measured by the fatigue symptom inventory (FSI) [ Time Frame: At baseline and after completion of study treatment, 4 years ] [ Designated as safety issue: No ]
  • Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI) [ Time Frame: At baseline and after completion of study treatment, 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value [ Time Frame: At baseline and after completion of study treatment, 4 years ] [ Designated as safety issue: No ]
  • Change in proinflammatory cytokines as measured by interleukin 6 value [ Time Frame: At baseline and after completion of study treatment, 4 years ] [ Designated as safety issue: No ]
  • Change in proinflammatory cytokines as measured by tumor necrosis factor [ Time Frame: At baseline and after completion of study treatment, 4 years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: February 2005
Study Completion Date: November 2012
Primary Completion Date: January 2007 (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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
American Cancer Society, Inc.
Investigators
Principal Investigator: Patricia A. Ganz, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00112749     History of Changes
Other Study ID Numbers: CDR0000428460  P30CA016042  UCLA-0410033-01 
Study First Received: June 2, 2005
Last Updated: February 12, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
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
Gastrointestinal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 06, 2016