Tookman, A. J., Jones, C. L., Dewitte, M., & Lodge, P. J. (2008). Fatigue in patients with advanced cancer: a pilot study of an intervention with infliximab. Supportive Care in Cancer, 16, 1131–1140.

In the original protocol, infliximab was given as an intravenous infusion at 5 mg/kg over a two-hour period, followed by a two-hour observation period, at baseline and two, four, and every four weeks after that if improvement was demonstrated. After a patient suffered a serious infection following the week 2 infusion, the dosing regimen was amended to 5 mg/kg at week 0 and every four weeks after if improvement was observed. The first five patients were treated under the original protocol, and the next 12 were treated according to the amended protocol. Patient outcomes were evaluated at every time point.

• The sample was comprised of 17 patients with end-stage cancer.
• Mean age was 63.5 years.
• The majority of the patients were male (76.5%) and had multiple cancer diagnoses, with the most common being renal cell carcinoma (23.5%) and nonsmall cell lung carcinoma (NSCLC) (23.5%).
• Patients were excluded if they had a reversible cause of fatigue (i.e., anemia, hypercalcemia, hyponatremia, or hypothyroidism) or had major surgery, chemotherapy, or radiotherapy within four weeks of study enrollment, which were medical contraindications for infliximab treatment.

Outpatient, daytime therapy clinics for specialist palliative care at the Marie Curie Hospice, United Kingdom

Patients were undergoing the palliative phase of care.

This was an open-label, pilot study.

Fatigue Severity Scale (FSS)

The infliximab intervention did not show an overall improvement of fatigue in patients. However, a small cohort of six patients showed an improvement in FSS scores over time with repeated infliximab infusions, although this difference did not reach statistical significance. The six patients shared a similar profile of NSCLC that was progressive through chemotherapy and received the amended protocol treatment.

• The study had a small sample size.
• The stuck lacked a neutral comparison group.