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Trial record 1 of 22 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.

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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

Tracking Information
First Submitted Date  ICMJE November 20, 2019
First Posted Date  ICMJE November 25, 2019
Last Update Posted Date November 25, 2019
Actual Study Start Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
Official Title  ICMJE Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Malignant Glioma
Intervention  ICMJE
  • Drug: Hydrogen
    Each hydrogen tablet contains 80 mg magnesium
    Other Name: H2
  • Drug: Placebo oral tablet
    Matching placebo tablet also contains 80 mg magnesium
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Hydrogen
  • 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.
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christine Pol, PhD 6314449083 christiana.pol@stonybrookmedicine.edu
Contact: Agnieszka Kowalska, MD 631-444-2599 agnieszka.kowalska@stonybrookmedicine.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04175301
Other Study ID Numbers  ICMJE IRB2019-00236
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Agnieszka Kowalska, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnieszka Kowalska, MD Stony Brook Medicine
PRS Account Stony Brook University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP