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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

infliximab

Clinical Assessment

Self-report questionnaires

Immune Assessment

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, breast cancer in situ, fatigue

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

Please see intervention description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Change in proinflammatory cytokines as measured by interleukin 6 value

Change in proinflammatory cytokines as measured by tumor necrosis factor

Full Information

NCT ID

NCT00112749

First Posted

June 2, 2005

Last Updated

July 29, 2020

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00112749

Brief Title

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

Official Title

Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.

Study Start Date

February 2005 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Fatigue

Keywords

stage I breast cancer, stage II breast cancer, breast cancer in situ, fatigue

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Arm

Arm Type

Experimental

Arm Description

Please see intervention description

Intervention Type

Biological

Intervention Name(s)

infliximab

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Clinical Assessment

Intervention Description

Medical, psychiatric, and immune evaluation.

Intervention Type

Other

Intervention Name(s)

Self-report questionnaires

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Immune Assessment

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame