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Trial record 1 of 23 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | glioma | United States | Start date from 08/08/2019 to 12/19/2019
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Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175301
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Agnieszka Kowalska, Stony Brook University

Brief Summary:
This is a pilot randomized control trial (RCT) to explore the effects of hydrogen rich water on quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Hydrogen Drug: Placebo oral tablet Phase 2

Detailed Description:

This will be a pilot trial exploring the ability of molecular hydrogen to improve quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide. Hydrogen has an excellent safety profile, has antioxidant properties and reduces inflammatory events in the tissues. It has been postulated in previous studies that continuous consumption of hydrogen water reduces oxidative stress in the brain by lowering the concentration of the reactive oxygen species, resulting in the improvement of adult neurogenesis or the stimulation of neural proliferation, leading to the prevention of the decline in the learning and memory.

This will be a double blinded, placebo-controlled trial. Eligible and willing subjects will be randomly assigned in a 2:1 ratio to be treated with either hydrogen or placebo, to receive hydrogen or placebo, additionally to all standard-of-care treatments. The treatment with hydrogen or placebo will start the day before chemoradiation therapy starts, and continue for six weeks. The effects of drinking hydrogen water on the quality of life will be assessed using the EORTC QLQ-C30 and the EORTC QLQ-BN20 questionnaires at baseline, at 6 weeks, 6 months, 12 months, 18 months and 24 months.

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Study Type : Interventional
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The subjects will be randomly assigned in a 2:1 ratio to receive hydrogen or placebo, additionally to all standard-of-care treatments by the SB Research Pharmacy. Masking of active and placebo treatments will be preserved by creating study medication containers that appear identical.
Primary Purpose: Treatment
Official Title: Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.
Actual Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Hydrogen
Five times per day for 6 weeks subjects will dissolve a hydrogen generating tablet into water and drink the effervescent water. Dissolving one tablet in 250 mL of water will achieve a saturating hydrogen concentration of approximately 1.6 ppm.
Drug: Hydrogen
Each hydrogen tablet contains 80 mg magnesium
Other Name: H2

Placebo Comparator: Placebo
Five times per day for 6 weeks subjects will dissolve an placebo tablet into water and drink the effervescent water. The effervescent placebo tablet does not generate hydrogen-enriched water.
Drug: Placebo oral tablet
Matching placebo tablet also contains 80 mg magnesium




Primary Outcome Measures :
  1. Patient enrollment statistics [ Time Frame: 3 years ]
    Feasibility of recruitment, assessment procedures, treatment, and outcome measures will be evaluated. Number of screened / eligible / enrolled patients, treatment adherence, assessment completion, subject dropout, data completeness, and data variability.


Secondary Outcome Measures :
  1. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score [ Time Frame: 2 years ]
    Change in health related quality of life from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the EORTC QLQ-C30 score. The score range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

  2. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score [ Time Frame: 2 years ]
    Change in health related quality of life from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the EORTC QLQ-BN20 score. The score range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.

  3. Memory [ Time Frame: 2 years ]
    Change in memory from baseline to week 6, month 6, month 12, month 18, and month 24, as assessed by the Mini-Mental State Examination (MMSE).

  4. Karnofsky performance score (KPS) [ Time Frame: 2 years ]
    Change in Karnofsky performance score (KPS) from baseline to week 6, month 6, month 12, month 18, and month 24.

  5. Overall survival and progression free survival (PFS) [ Time Frame: 2 years ]
    Overall survival is defined as the time from randomization until death from any cause. PFS is defined as the time from randomization until tumor progression (defined by McDonald's criteria).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 years old or over
  • New diagnosis of a malignant glioma (HGG) either by a biopsy or craniotomy
  • KPS of at least 70
  • Being able to fill out quality of life questionnaire

Exclusion Criteria:

  • Other major diseases of the central nervous system, including history of prior brain tumors, Alzheimer's disease, Parkinson's disease, demyelinating disease, inflammatory brain or vascular disease, traumatic encephalopathy, or idiopathic intracranial hypertension, anxiety/depression.
  • Pre-existing neurological disability, unable to read or write
  • Severe comorbidities likely to result in patient dying within 3 months
  • Prior history of radiation therapy
  • Prior use of chemotherapy
  • History of other cancers
  • Inability to safely tolerate the 1500 ml- 2000ml fluid load (po water) associated with study medication*
  • Pregnancy or nursing.
  • Treatment with another investigational drug within the last 30 days that may interfere with this study's medications*
  • Hypersensitivity to Temozolomide and or it's active agent- Dacarbazine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175301


Contacts
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Contact: Christine Pol, PhD 6314449083 christiana.pol@stonybrookmedicine.edu
Contact: Agnieszka Kowalska, MD 631-444-2599 agnieszka.kowalska@stonybrookmedicine.edu

Locations
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United States, New York
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794-8121
Contact: Christine Pol, PhD    631-444-9083    christiana.pol@stonybrookmedicine.edu   
Contact: Agnieszka Kowalska, MD    631-444-2599    agnieszka.kowalska@stonybrookmedicine.edu   
Sub-Investigator: Dennis Choi, MD, PhD         
Sub-Investigator: Samuel Ryu, MD         
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Agnieszka Kowalska, MD Stony Brook Medicine
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Responsible Party: Agnieszka Kowalska, Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT04175301    
Other Study ID Numbers: IRB2019-00236
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agnieszka Kowalska, Stony Brook University:
neuroprotection
hydrogen
antioxidant
malignant glioma
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue