Low Dose Naltrexone for Glioma Patients

NCT01303835 | Completed Phase 2 Results

• 1 other identifier: Pro00027661
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high grade glioma patients undergoing standard chemoradiation

Conditions

Malignant Glioma

Keywords

malignant glioma; glioblastoma multiforme; quality of life; naltrexone

Outcome Measures

Primary Outcomes (1)

• Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline

  The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated. * Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132) * Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients' usual daily activities (range 0-52) * Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24) * Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain) * Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference

  Baseline and 16 weeks

Secondary Outcomes (2)

• Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline

  Baseline and 16 weeks

• Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline

  Baseline and 16 weeks

Study Arms (2)

Naltrexone

EXPERIMENTAL

Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.

Drug: LDN

Placebo

PLACEBO COMPARATOR

Randomized patients received placebo to be taken every night before bed.

Drug: Placebo

Interventions

LDN DRUG

Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.

Also known as: Low dose naltrexone, ReVia

Naltrexone

Placebo DRUG

Randomized patients received placebo to be taken every night before bed.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent prior to beginning specific protocol procedures
• histologically proven high-grade glioma
• planned treatment with concurrent radiotherapy and daily oral temozolomide (with or without Avastin)
• ≥ 18 years of age
• Karnofsky performance index ≥ 70%
• must be able to ambulate unassisted for 6 minutes safely
• The Preston Robert Tisch Brain Tumor Center (PRT-BTC) neuro-oncologist's approval
• hematocrit ≥ 29%, hemoglobin ≥ 9, absolute neutrophil count (ANC) ≥ 1,500 cells/microliter, platelets ≥ 100,000 cells/microliter
• serum creatinine \< 1.5 times upper limit of normal, serum glutamic oxaloacetic transaminase (SGOT) \< 2.5 times upper limit of normal and bilirubin \< 2.0 times upper limit of normal
• if sexually active, patients will take contraceptive measures for the duration of the treatments
• Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of study drug

You may not qualify if:

• prior therapy with naltrexone or naloxone
• co-medication that may interfere with study results, e.g. opioids,
• known hypersensitivity to any component of naltrexone
• pregnant (positive pregnancy test) or lactating

Sponsors & Collaborators

• Katy Peters: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Peters KB, Affronti ML, Woodring S, Lipp E, Healy P, Herndon JE 2nd, Miller ES, Freeman MW, Randazzo DM, Desjardins A, Friedman HS. Effects of low-dose naltrexone on quality of life in high-grade glioma patients: a placebo-controlled, double-blind randomized trial. Support Care Cancer. 2022 Apr;30(4):3463-3471. doi: 10.1007/s00520-021-06738-0. Epub 2022 Jan 10.

  PMID: 35001215 DERIVED

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Katherine B. Peters, MD, PhD
• Organization: Duke University Medical Center, The Preston Robert Tisch Brain Tumor Center

katherine.peters@duke.edu

(919) 684-6173

Study Officials

• Katherine B Peters, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 25, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: May 1, 2015
• Last Updated: July 17, 2015
• Results First Posted: June 26, 2015

Record last verified: 2015-06

Locations

US (1)