Low Dose Naltrexone for Glioma Patients
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Glioma
Intervention: LDN (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Katy Peters Official(s) and/or principal investigator(s): Katherine B Peters, MD, PhD, Principal Investigator, Affiliation: Duke University
Summary
To compare the effects of low dose naltrexone (LDN) versus placebo on quality of life in
high grade glioma patients undergoing standard chemoradiation
Clinical Details
Official title: Effects of Low Dose Naltrexone on Quality of Life in High Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline
Secondary outcome: Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From BaselineEffects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline
Detailed description:
The proposed study is a placebo-controlled, randomized clinical trial. Potential
participants will be identified via clinical protocol chart review of patients scheduled to
attend their predetermined follow-up consultations at The Preston Robert Tisch Brain Tumor
Center (PRT-BTC) at Duke University Medical Center after evaluation of treatment for newly
diagnosed high grade gliomas. We will identify high grade glioma patients that will receive
standard chemoradiation (radiotherapy with daily temozolomide dosed at 75 mg/m2). After
obtaining written informed consent, all participants will be scheduled for baseline study
assessments before starting radiotherapy. Patients will be randomized to receive either
placebo or low dose naltrexone (LDN) dosed at 4. 5 mg orally to be taken every evening before
going to bed. Patients will be assessed at the following time points: 1. Baseline (before
chemoradiation), 2. After chemoradiation (approximately 8 weeks from initial assessment), 3.
Two months after standard chemoradiation (approximately 16 weeks after initial assessment),
and 4. Four months after standard chemoradiation (approximately 24 weeks after initial
assessment). Treatment with LDN or placebo will begin on first day of chemoradiation and
will be continued for a total of 16 weeks from initial assessment. Last assessment at 24
weeks will occur 8 weeks after discontinuation of LDN or placebo. All visits will be
linked to patients' clinical management visits. All testing will be performed at PRT-BTC
and at Duke University Medical Center.
The following procedures will be obtained at each assessment visit:
1. Complete a six-minute walk test. The exercise test is designed to determine how far the
subject can walk in six minutes. This test will take place at the PRT-BTC at Duke
University Medical Center with appropriate medical supervision.
2. Blood testing that will be performed as part of each clinic visit. Approximately 10
milliliters or 2 teaspoons of blood will be drawn at each visit. This will not be
additional blood work, but rather the standardized blood work that the subject will
need for evaluation associated with radiation and chemotherapy treatments.
We will ask the subject to complete the following tests/questionnaires:
1. Neurocognitive testing: this testing will be performed using a computer program called
CNS Vital Signs®. This program consists of verbal and visual memory tests, attention
tests, reasoning tests, and speed of processing tests. The subject will use a laptop
computer to complete these tests. No previous exposure to computers or computer
testing is needed to complete the test.
2. Computerized Questionnaires: Four questionnaires will be presented using a
computerized program. These will include Medical Outcomes Survey (MOS), Epworth
Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), and Zung Self-Rating
Depression Scale (ZSDS). MOS assesses general health, well-being, and quality of life.
ESS asks about level of sleepiness while PSQI asks about sleep quality. Finally, ZSDS
will evaluate feelings of depression and sadness.
3. Beck depression inventory (BDI): This questionnaire asks questions about the subject's
levels of sadness, changes in the subject's mood, sleeping and eating patterns, the
subject's level of interest in activities, thoughts and feelings the subject is having
and the subject's level of concentration. This is a pen and paper questionnaire.
4. Functional Assessment of Cancer Therapy-Brain (FACT-BR) scale: This questionnaire asks
questions about physical, function, emotional, and social well-being. This is a pen
and paper questionnaire.
5. Functional Assessment of Cancer Therapy-Fatigue (FACIT-F) scale: This questionnaire
asks questions about fatigue. This is a pen and paper questionnaire.
6. Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) scale: This questionnaire
asks questions about your thinking and ability to do memory, attention, and reasoning
activities. This is a pen and paper questionnaire.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Duke University Medical Center, Durham, North Carolina 27710, United States
Additional Information
Starting date: May 2011
Last updated: June 25, 2015
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