Clinical trial NCT04175301: 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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Malignant Glioma
Keywords: neuroprotection
hydrogen
antioxidant
malignant glioma
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Patient enrollment statistics
timeFrame: 3 years
Secondary outcomes:
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) C30 score
timeFrame: 2 years
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) BN20 score
timeFrame: 2 years
measure: Memory
timeFrame: 2 years
measure: Karnofsky performance score (KPS)
timeFrame: 2 years
measure: Overall survival and progression free survival (PFS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
Study officials:
affiliation: Stony Brook Medicine
name: Agnieszka Kowalska, MD
role: PRINCIPAL_INVESTIGATOR
References: