Evidence map›Paper›PMID 35001215›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2022

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

Katherine B Peters, Mary L Affronti, Sarah Woodring, Eric Lipp, Patrick Healy, James E Herndon, Elizabeth S Miller, Maria W Freeman, Dina M Randazzo, Annick Desjardins and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01303835 (Effects of Low Dose Naltrexone on Quality of Life in High Grade Glioma Patients), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01303835 phase2completednot on this map

Effects of Low Dose Naltrexone on Quality of Life in High Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial

TypeinterventionalSponsorKaty PetersRan2011 to 2015Enrolled110ConditionsMalignant GliomaArmsLDN, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Therapeutic Approaches to the Neurologic Manifestations of COVID-19.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Katherine B PetersDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA. katherine.peters@duke.edu.
Mary L AffrontiDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Sarah WoodringDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Eric LippDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Patrick HealyDepartment of Biostatistics and Informatics, Duke University Medical Center, Durham, NC, USA.
James E HerndonDepartment of Biostatistics and Informatics, Duke University Medical Center, Durham, NC, USA.
Elizabeth S MillerDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Maria W FreemanDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Dina M RandazzoDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Annick DesjardinsDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Henry S FriedmanDepartment of Neurosurgery, Duke University Medical Center, PO Box 3624, Durham, NC, 27710, USA.
Duke University Hospital · USDuke Medical Center · USDuke University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAt 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.

methodsIn 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.

resultsDemographics 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.

conclusionsLDN has no effect on QOL and fatigue in HGG patients during concurrent chemotherapy and radiation therapy.

trial registrationUnited States National Library of Medicine Clinical Trials.gov NCT01303835, Date 2/25/2011.

Indexed as

GliomaQuality of LifeDouble-Blind MethodHumansMaleMiddle AgedNaltrexoneTemozolomideNaltrexoneTemozolomideFatigueGliomaHigh-gradeLow-doseNaltrexoneQuality of life

Identifiers

PMID35001215
OpenAlexW4226062712

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.