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

July 29, 2020 updated by: Jonsson Comprehensive Cancer Center

Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fatigue as measured by the fatigue symptom inventory (FSI)
Time Frame: At baseline and after completion of study treatment, 4 years
At baseline and after completion of study treatment, 4 years
Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)
Time Frame: At baseline and after completion of study treatment, 4 years
At baseline and after completion of study treatment, 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value
Time Frame: At baseline and after completion of study treatment, 4 years
At baseline and after completion of study treatment, 4 years
Change in proinflammatory cytokines as measured by interleukin 6 value
Time Frame: At baseline and after completion of study treatment, 4 years
At baseline and after completion of study treatment, 4 years
Change in proinflammatory cytokines as measured by tumor necrosis factor
Time Frame: At baseline and after completion of study treatment, 4 years
At baseline and after completion of study treatment, 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Patricia A. Ganz, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 2, 2005

First Submitted That Met QC Criteria

June 2, 2005

First Posted (Estimate)

June 3, 2005

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000428460
  • UCLA-0410033-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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