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

This study has been completed.
Sponsor:
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
  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 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
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
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014