Clinical trial · Interventional
Low Dose Naltrexone for Glioma Patients
Effects of Low Dose Naltrexone on Quality of Life in High Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial
NCT01303835CI-TRIAL-00018571completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high grade glioma patients undergoing standard chemoradiation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDN | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Naltrexone
- description
- Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
- interventionNames
- Drug: LDN
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Randomized patients received placebo to be taken every night before bed.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDPeters 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