Phase 2
N=110
Low Dose Naltrexone for Glioma Patients
Malignant Glioma
Bottom Line
View on ClinicalTrials.gov: NCT01303835 ↗Enrolled (actual)
110
Serious AEs
26.4%
Results posted
Jun 2015
Primary outcome: Primary: Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline — -3.73; -6.06; -4.22; -4.1 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LDN (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Katy Peters
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline |
-3.73; -6.06; -4.22; -4.1; 3.47; 0.81 | — |
| SECONDARY Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline |
13.43; -6.42 | — |
| SECONDARY Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline |
-5.38; -0.24; -0.71; 7.32; -7.24; -8.64 | — |
Summary
To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in high grade glioma patients undergoing standard chemoradiation
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01303835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.