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Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.

Sponsor
Stony Brook University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04175301
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
48
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 31, 2019
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Patient enrollment statistics [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 [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 [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 [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) [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) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 head/neck radiation therapy

    • Other active cancer or history of other cancer diagnosed within 5 year.

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stony Brook University Medical Center Stony Brook New York United States 11794-8121

    Sponsors and Collaborators

    • Stony Brook University

    Investigators

    • Principal Investigator: Agnieszka Kowalska, MD, Stony Brook Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Agnieszka Kowalska, Assistant Professor, Stony Brook University
    ClinicalTrials.gov Identifier:
    NCT04175301
    Other Study ID Numbers:
    • IRB2019-00236
    First Posted:
    Nov 25, 2019
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Agnieszka Kowalska, Assistant Professor, Stony Brook University
    neuroprotection
    hydrogen
    antioxidant
    malignant glioma
    Additional relevant MeSH terms:
    Glioma

    Study Results

    No Results Posted as of Mar 23, 2021