A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the
effect of modafinil on cancer-related fatigue among 631 patients receiving
chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology
Program Research base study.
Author(s): Jean-Pierre P, Morrow GR, Roscoe JA, Heckler C, Mohile S, Janelsins M, Peppone L,
Hemstad A, Esparaz BT, Hopkins JO.
Affiliation(s): Department of Pediatrics, University of Miami School of Medicine, and Sylvester
Comprehensive Cancer Center, Miami, Florida 33101, USA.
PJean-Pierre@med.miami.edu
Publication date & source: 2010, Cancer. , 116(14):3513-20
BACKGROUND: Cancer-related fatigue is a debilitating symptom affecting
psychosocial functioning and quality of life in 70% to 100% of cancer patients
during and after treatment. The authors examined the effect of 200 mg of
modafinil daily on the severity of cancer-related fatigue.
METHODS: The authors conducted a multicenter, randomized, double-blind,
placebo-controlled, phase 3, clinical trial to examine the effect of modafinil on
patient-reported fatigue in cancer patients undergoing chemotherapy. A sample of
877 cancer patients beginning chemotherapy at 23 geographically separate
University of Rochester Cancer Center (URCC) Community Clinical Oncology Program
(CCOP) affiliates were assessed for fatigue. Patients who reported fatigue
(N=867) were randomly assigned to receive either 200 mg of oral modafinil
(Provigil) daily or a placebo. Treatment began on Day 5 of Cycle 2 and ended
after Day 7 of Cycle 4. Fatigue and depression were assessed during Cycles 2 to 4
by using psychometrically valid measures. Group differences (treatment vs
control) in the worst level of fatigue during the previous week at Cycle 4 were
examined by using an analysis of covariance (ANCOVA) adjusting for baseline
fatigue (Cycle 2).
RESULTS: There were 631 patients (315 modafinil, 316 placebo) who provided
evaluable data. ANCOVA showed a significant interaction between treatment
condition and baseline fatigue (P=.017), where patients with severe baseline
fatigue (n=458) benefited from modafinil, whereas patients with mild or moderate
fatigue did not. Modafinil had no statistically significant effect on depression
(P>.05).
CONCLUSIONS: Modafinil may be useful in controlling cancer-related fatigue in
patients who present with severe fatigue but is not useful in patients with mild
or moderate fatigue.
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