NCT00112749

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 31, 2020

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

June 2, 2005

Last Update Submit

July 29, 2020

Conditions

Breast CancerFatigue

Keywords

stage I breast cancerstage II breast cancerbreast cancer in situfatigue

Outcome Measures

Primary Outcomes (2)

  • Change in fatigue as measured by the fatigue symptom inventory (FSI)

    At baseline and after completion of study treatment, 4 years

  • Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)

    At baseline and after completion of study treatment, 4 years

Secondary Outcomes (3)

  • Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value

    At baseline and after completion of study treatment, 4 years

  • Change in proinflammatory cytokines as measured by interleukin 6 value

    At baseline and after completion of study treatment, 4 years

  • Change in proinflammatory cytokines as measured by tumor necrosis factor

    At baseline and after completion of study treatment, 4 years

Study Arms (1)

Study Arm

EXPERIMENTAL

Please see intervention description

Biological: infliximabOther: Clinical AssessmentOther: Self-report questionnairesOther: Immune Assessment

Interventions

infliximabBIOLOGICAL

A single infusion of 1mg/kg will be administered.

Study Arm
Clinical AssessmentOTHER

Medical, psychiatric, and immune evaluation.

Study Arm
Self-report questionnairesOTHER

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.

Study Arm
Immune AssessmentOTHER

Proinflammatory cytokines and markers of cytokine activity and lymphocyte subsets and CBC.

Study Arm

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsFatigueBreast Carcinoma In Situ

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Patricia A. Ganz, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2005

First Posted

June 3, 2005

Study Start

February 1, 2005

Primary Completion

January 1, 2007

Study Completion

November 1, 2012

Last Updated

July 31, 2020

Record last verified: 2016-02

Locations

US(1)