Clinical Trials for Adults | Effects of Low-Dose Naltrexone on Quality of Life in High-Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial
Purpose of this study
To compare the effects of low-dose naltrexone versus placebo on quality of life, functional capacity and neurocognition in newly diagnosed high-grade glioma patients undergoing standard chemoradiation
Eligibility, Inclusion
- Histologically proven high-grade glioma
- Planned treatment with concurrent radiotherapy and daily oral Temozolomide (Avastin OK)
- ≥ 18 years of age
- Karnofsky performance index ≥ 70%
- No documented cardiac or pulmonary disease
- No contraindications to six-minute walk test
- Primary neuro-oncologist approval
- Hematocrit ≥ 29%, hemoglobin ≥ 9, ANC ≥ 1,500 cells/l, platelets ≥ 100,000 cells/l,
- Serum creatinine < 1.5 times upper limit of normal, serum 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.
Exclusion Criteria
- Prior therapy with naltrexone or naloxone
- Co-medication that may interfere with study results; e.g. opioids (hydrocodone, morphine, oxycodone, methadone, or codeine while on study)
- Known hypersensitivity to any component of naltrexone
- Pregnant (positive pregnancy test within 48 hours of starting chemoradiation) or lactating
Study Design: Key Features
- Patients will be randomly assigned to either 4.5mg Naltrexone or placebo
- 72 patients will be treated on this protocol
- Naltrexone and placebo are provided free by the study
- Drug will be taken every night at bedtime for 16 weeks starting the first day of chemoradiation
- Study lasts 24 weeks
- All visits linked to regularly scheduled clinic visits
- Blood work -weekly for 24 weeks
- Assessments will be done 4 times over the course of the study (at baseline, after chemoradiation, 2 and 4 months after chemo) via a computerized program, and paper surveys along with a six minute walk test
Expected Toxicities
- Less likely-vivid dreams
- Rare- nausea, vomiting, loss of appetite, headache, dizziness, anxiety, nervousness, fatigue, trouble sleeping, drowsiness, abdominal pain, bone/joint pain, muscle aches, nasal symptoms
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