Effects of low-dose naltrexone on quality of life in high-grade glioma patients: a placebo-controlled, double-blind randomized trial.

Autor: Peters KB; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA. katherine.peters@duke.edu.; Department of Neurology, Duke University Medical Center, Durham, NC, USA. katherine.peters@duke.edu., Affronti ML; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.; Duke School of Nursing, Duke University Medical Center, Durham, NC, USA., Woodring S; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA., Lipp E; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA., Healy P; Department of Biostatistics and Informatics, Duke University Medical Center, Durham, NC, USA., Herndon JE 2nd; Department of Biostatistics and Informatics, Duke University Medical Center, Durham, NC, USA., Miller ES; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA., Freeman MW; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA., Randazzo DM; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.; Department of Neurology, Duke University Medical Center, Durham, NC, USA., Desjardins A; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.; Department of Neurology, Duke University Medical Center, Durham, NC, USA., Friedman HS; Department of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Jazyk: angličtina
Zdroj: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer [Support Care Cancer] 2022 Apr; Vol. 30 (4), pp. 3463-3471. Date of Electronic Publication: 2022 Jan 10.
DOI: 10.1007/s00520-021-06738-0
Abstrakt: Purpose: 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.
Methods: In a placebo-controlled, double-blind study, we randomized 110 HGG patients to receive placebo (N = 56) or LDN 4.5 mg orally at night (N = 54). Subjects received LDN or placebo at day 1 of concurrent radiation and temozolomide therapy and continued for 16 weeks. 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.
Results: Demographics were WHO grade IV (85%), male (56%), KPS 90-100 (51%), grossly resected (55%), and mean age of 56 years. 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.
Conclusions: LDN has no effect on QOL and fatigue in HGG patients during concurrent chemotherapy and radiation therapy.
Trial Registration: United States National Library of Medicine Clinical Trials.gov NCT01303835, Date 2/25/2011.
(© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
Databáze: MEDLINE
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