Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Stony Brook University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Patient enrollment statistics
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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: Hydrogen (Drug)
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: Placebo oral tablet (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score(2 years)
- European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score(2 years)
- Memory(2 years)
- Karnofsky performance score (KPS)(2 years)
- Overall survival and progression free survival (PFS)(2 years)
Investigators
Agnieszka Kowalska
Assistant Professor
Stony Brook University