Abstract
At diagnosis and throughout the disease course, patients with high-grade glioma (HGG) experience a diminished quality of life (QOL) and increased fatigue. Naltrexone, an orally semisynthetic opiate antagonist, is FDA-approved for the treatment of heroin/alcohol addiction, and low-dose naltrexone (LDN) has been observed to improve QOL and lower fatigue in other neurological illnesses, such as multiple sclerosis. LDN is believed to function as a partial agonist and can lead to shifts in neurochemicals that reduce fatigue. Based on this, we sought to study whether LDN has an impact on QOL and fatigue in patients with HGG. In a placebo-controlled, double-blind study, we randomized 110 HGG patients to receive placebo (N = 56) or LDN 4.5mg orally at night (N = 54). Subjects received LDN or placebo at day 1 of concurrent radiation and temozolomide therapy and continued for 16weeks. Change from baseline in patient-reported outcomes of QOL (Functional Assessment of Cancer Therapy-Brain) and fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) was assessed. Demographics were WHO grade IV (85%), male (56%), KPS 90-100 (51%), grossly resected (55%), and mean age of 56years. QOL and fatigue changes between baseline and post concurrent chemotherapy and radiation therapy were not significantly different between patients receiving LDN or placebo. The adverse event profiles for LDN and placebo were similar and attributed to concomitant use of temozolomide. LDN has no effect on QOL and fatigue in HGG patients during concurrent chemotherapy and radiation therapy. United States National Library of Medicine Clinical Trials.gov NCT01303835, Date 2/25/2011.
Highlights
Primary brain tumors represent 1% of all diagnosed cancers [1]
While safe to administer, low-dose naltrexone (LDN) has no effect on quality of life (QOL) and fatigue in high-grade glioma (HGG) patients during concurrent chemotherapy and radiation therapy
While we did complete this randomized, placebo-controlled study of LDN in newly diagnosed HGG patients and did find that reported levels of QOL impairment and fatigue increased after concurrent chemotherapy and radiation therapy, we did not demonstrate that the use of LDN statically improves QOL or fatigue in our patients
Summary
Primary brain tumors represent 1% of all diagnosed cancers [1]. The standard of care for newly diagnosed high-grade gliomas (HGGs) involves surgical resection followed by temozolomide concurrently with and after radiotherapy. Before and during treatment for high-grade gliomas, adult patients experience a decline in perceived quality of life (QOL) [2, 3]. Liu and colleagues discuss how these symptoms and signs are interrelated and argue that they should not be studied alone as cognitive decline/dysfunction was associated with increased fatigue and poorer performance status [7, 3, 8]. During concurrent chemotherapy and radiation therapy, brain tumor patients experience a decline in relative QOL, mainly due to fatigue and changes in cognition [9, 10]. Our group published that in recurrent high-grade glioma patients, reported levels of fatigue was a strong independent predictor of survival, with patients with higher levels of reported fatigue having a poorer survival [11]
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