Low-Dose Naltrexone for Glioma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Katy Peters, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01303835
First received: February 23, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Malignant Glioma
Drug: Naltrexone
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Low-Dose Naltrexone on Quality of Life in High-Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Effects of low-dose naltrexone versus placebo on quality of life in high-grade glioma patients undergoing standard chemoradiation. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Patient-Reported Outcomes as assessed by standardized and validated questionnaires including: Quality of Life; Fatigue; Cognition; Depression; Computerized Battery from CNS Vital Signs (Medical Outcomes Survey, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Zung Self-Rating Depression Scale)


Secondary Outcome Measures:
  • Compare the effects of low-dose naltrexone versus placebo on functional capacity and compare the effects on neurocognition in high-grade glioma patients [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    • Functional Capacity (Six-minute walk test)
    • Neurocognitive Function (a computerized neurocognitive test battery called CNS Vital Signs® including verbal memory test, visual memory test, finger tapping test, symbol digit coding, Stroop test, shifting attention test, continuous performance test)
    • Adverse Event Monitoring
    • Laboratory Testing


Estimated Enrollment: 130
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quality of Life
Patients will be randomized to receive either placebo or LDN dosed at 4.5 mg orally to be taken every evening before going to bed.
Drug: Naltrexone
Low-dose Naltrexone dosed at 4.5 mg by mouth every evening before going to bed.
Other Names:
  • LDN
  • ReVia
Placebo Comparator: Placebo
Patients will be randomized to receive either placebo or LDN dosed at 4.5 mg orally to be taken every evening before going to bed.
Drug: Naltrexone
Low-dose Naltrexone dosed at 4.5 mg by mouth every evening before going to bed.
Other Names:
  • LDN
  • ReVia
Other: Placebo
Patients will be randomized to receive either placebo or naltrexone (LDN) dosed at 4.5 mg orally to be taken every evening before going to bed.
Other Name: Gliomas

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 LDN dosed at 4.5 mg orally to be taken every evening before going to bed. Patients will be assessed at the following timepoints: 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). (See Figure 1 for study design) 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 discontinued 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 cc 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, ANC ≥ 1,500 cells/microliter, platelets ≥ 100,000 cells/microliter,
  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303835

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Katy Peters
Investigators
Principal Investigator: Katherine B Peters, MD, PhD Duke University
  More Information

No publications provided

Responsible Party: Katy Peters, Assistant Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01303835     History of Changes
Other Study ID Numbers: Pro00027661
Study First Received: February 23, 2011
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
malignant glioma
glioblastoma multiforme
quality of life
naltrexone

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Naltrexone
Glioma
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014