Clinical trial · Interventional
Infliximab in Treating Cancer-Related Fatigue in Postmenopausal Women Who Have Undergone Treatment for Breast Cancer
Does Blocking Proinflammatory Cytokines Diminish Cancer-Related Fatigue?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment stopped due to slow accrual and lack of evidence of need for further continuation of protocol in inpatient setting.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Assessment | Other | — | UNRESOLVED |
| Immune Assessment | Other | — | UNRESOLVED |
| infliximab | Biological | — | UNRESOLVED |
| Self-report questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Arm
- description
- Please see intervention description
- interventionNames
- Biological: infliximab
- Other: Clinical Assessment
- Other: Self-report questionnaires
- Other: Immune Assessment
Primary outcomes (2)
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available