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

• ClinicalTrials.gov Identifier: NCT04175301
• Recruitment Status: Recruiting
• First Posted: November 25, 2019
• Last Update Posted: November 25, 2019
• Sponsor: Stony Brook University
• Information provided by (Responsible Party): Agnieszka Kowalska, Stony Brook University

Tracking Information

• First Submitted Date: November 20, 2019
• First Posted Date: November 25, 2019
• Last Update Posted Date: November 25, 2019
• Actual Study Start Date: October 31, 2019
• Estimated Primary Completion Date: October 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
• Official Title: 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: Interventional
• Study Phase: Phase 2

Study Design

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: Malignant Glioma

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 21, 2019): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2023
• Estimated Primary Completion Date: October 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christine Pol, PhD; 6314449083; christiana.pol@stonybrookmedicine.edu

Contact: Agnieszka Kowalska, MD; 631-444-2599; agnieszka.kowalska@stonybrookmedicine.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04175301
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Agnieszka Kowalska, Stony Brook University
• Study Sponsor: Stony Brook University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Stony Brook University
• Verification Date: November 2019