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DOI Link

Intervention Characteristics/Basic Study Process

  • Cohort A: Six patients received docetaxel (43 mg/m2) weekly for six weeks every eight weeks.
  • Cohort B: Six patients received docetaxel weekly combined with etanercept (25 mg subcutaneously) twice weekly in addition to the docetaxel dosing schedule observed in Cohort A.
  • Cohort C: Six patients received docetaxel at a higher dose (52 mg/m2) weekly combined with etanercept (25 mg subcutaneously) twice a week for six weeks.
  • Cohort D: Eight patients received docetaxel (52 mg/m2) weekly combined with etanercept (25 mg subcutaneously) twice a week and G-CSF (5 ug/kg per day for four consecutive days starting the day after each docetaxel administration).
  • Outcomes were assessed at baseline and each week.

Sample Characteristics

N = 28

MEDIAN AGE = 56 years

AGE RANGE = 25–83 years

MALES = 17

KEY DISEASE CHARACTERISTICS: Most had received previous chemotherapy and/or radiotherapy and had multiple disease sites. The most common disease site was non-small-cell lung.

EXCLUSION CRITERIA: Patients were excluded if they were scheduled for major surgery, radiotherapy, or chemotherapy within 28 days of study entry or had brain metastases, serious infections, or psychiatric disorders that would interfere with consent or follow-up; pre-existing moderate-to-severe peripheral neuropathy; or cardiac disease. Pregnant or lactating women also were excluded.

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

  • Pilot feasibility study

Measurement Instruments/Methods

  • National Cancer Institute (NCI) fatigue grade assessment
  • Fatigue Symptom Inventory (FSI)

Results

Patients randomly were selected to receive etanercept/docetaxel. Less fatigue was self-reported in comparison to patients who received docetaxel only (p < 0.001). The FSI Interference score of Cohort A was significantly greater than the score of Cohort B (p < 0.001). Patients receiving additional cycles for treatment (Cohorts B,C, and D) did not experience worsening fatigue.

Limitations

  • Pilot study and therefore lacking a neutral comparison group
  • Small sample size
  • Fatigue assessment endpoints were not predetermined