“Other, preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients,” the researchers conclude.
Ms. Florien W. Boele, at the VU University Medical Center in Amsterdam, and colleagues note that a high prevalence of fatigue, cognitive impairment and depression has a large impact on health-related quality of life in patients with brain tumors. Based on the reported beneficial effects of modafinil on cognitive function, as well as fatigue and mood, the team conducted a multicenter double-blind placebo-controlled crossover trial to test the effects of the drug in 37 patients with glioma or meningioma.
Patients were randomized to receive modafinil or placebo for 6 weeks and were then switched to the opposite treatment after a 1-week washout period. Assessments were made at baseline and immediately after the two treatment periods.
“Contrary to our hypotheses, we did not find beneficial effects of modafinil on fatigue, depression, overall HRQOL, or cognitive functioning in comparison with placebo,” the team reports in Neuro-Oncology online August 7.
For example, the baseline fatigue score of 93.80 fell to 79.73 after 6 weeks of modafinil treatment and to 82.48 after placebo – a non-significant difference between the two treatment arms. The score for subjective cognitive functioning fell from 31.79 to 29.11 with modafinil and to 27.49 with placebo – a trend favoring placebo treatment (p=0.056).
Neither treatment improved depression scores significantly; the baseline depression score of 15.86 changed only slightly to 14.16 with modafinil and to 13.97 with placebo.
During recruitment, the authors found brain-tumor patients to be generally reluctant to participate in a pharmacologic trial for symptom management. Given the lack of benefit they documented, and the availability of possible alternative approaches, they conclude: “We recommend the development of nonpharmacologic interventions aimed specifically at symptom management in PBT patients, which may alleviate their symptom burden substantially and could improve their HRQOL significantly.