Methylphenidate (MP) and nursing telephone intervention (NTI) for cancer-related fatigue (CRF) in advanced cancer patients: A double-blind randomized phase II trial.

Abstract

9023 Background: CRF is the most common and distressing symptom in advanced cancer patients. Preliminary studies support MP and NTI for CRF (Bruera et al. JCO 2006). The primary objective of our study was to determine the effect of MP as compared to placebo (P). A secondary objective was to investigate the role of NTI as compared to control telephone intervention (CTI). Methods: Advanced cancer patients with fatigue ≥4/10 on the Edmonton Symptom Assessment Scale (ESAS), normal cognition, no evidence of major depression and hemoglobin ≥8 were eligible. Patients were randomized to 4 groups in a 2x2 factorial design (MP+NTI, P+NTI, MP+CTI and P+CTI). Primary endpoint was Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores between day 15 and baseline. The dose and duration of methylphenidate was 5 mg every two hours, as needed, up to 20 mg/day. We tested the median difference in FACIT-F subscale scores between the groups using the Kruskal Wallis test and Wilcoxon signed rank test. Longitudinal regression analysis was conducted with a mixed model. Results: Total accrual was 197. Mean (SD) age was 58 (12), female 67% (N=148), white 72% (N=136), gastrointestinal cancers were the most common 22% (N=41). Baseline FACIT-F subscores were similar among the 4 groups. The median FACIT-F subscores showed significant improvement between Day 15 and baseline for all four groups except for P+CTI (Table): MP+NTI (4.5, P=0.004), P+NTI (8, P<0.001), MP+CTI (7, P<0.001), and P+CTI (5, P=0.06), with no statistically significant difference between MP and P (6 vs. 6, P=0.89). Longitudinal regression analysis showed a time effect (P<0.001) and group differences for NTI vs. CTI with FACIT-F (P=0.13) and ESAS (P=0.03). Grade 3 toxicities were similar between the MP and P arms (34/93 vs. 24/97, P=0.09). Conclusions: MP was not effective as compared to P for CRF in advanced cancer patients. NTI may be effective and should be further studied. [Table: see text]