Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?


Phase 2
45 Years
65 Years
Not Enrolling
Female
Breast Cancer, Fatigue

Thank you

Trial Information

Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Fatigue as measured by the fatigue symptom inventory (FSI) at baseline and after completion of study treatment

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Patricia A. Ganz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000428460

NCT ID:

NCT00112749

Start Date:

February 2005

Completion Date:

January 2009

Related Keywords:

  • Breast Cancer
  • Fatigue
  • stage I breast cancer
  • stage II breast cancer
  • breast cancer in situ
  • fatigue
  • Breast Neoplasms
  • Fatigue

Name

Location
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781