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

NCT00112749 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-07-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Patricia A. Ganz, MD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-01-31
Completion
2012-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00112749 on ClinicalTrials.gov