Clinical trial NCT00112749: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Fatigue
Keywords: stage I breast cancer
stage II breast cancer
breast cancer in situ
fatigue
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2005-06-03
Enrollment: 7
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fatigue as measured by the fatigue symptom inventory (FSI)
timeFrame: At baseline and after completion of study treatment, 4 years
measure: Change in fatigue as measured by multidimensional fatigue symptom inventory (MFSI)
timeFrame: At baseline and after completion of study treatment, 4 years
Secondary outcomes:
measure: Change in proinflammatory cytokines as measured by interleukin-1 receptor antagonist value
timeFrame: At baseline and after completion of study treatment, 4 years
measure: Change in proinflammatory cytokines as measured by interleukin 6 value
timeFrame: At baseline and after completion of study treatment, 4 years
measure: Change in proinflammatory cytokines as measured by tumor necrosis factor
timeFrame: At baseline and after completion of study treatment, 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Patricia A. Ganz, MD
role: PRINCIPAL_INVESTIGATOR
References: