Clinical trial · Interventional
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.
Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.
NCT04175301CI-TRIAL-00092763active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrogen | Drug | — | UNRESOLVED |
| Placebo oral tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hydrogen
- description
- 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.
- interventionNames
- Drug: Hydrogen
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Drug: Placebo oral tablet
Primary outcomes (1)
- measure
- Patient enrollment statistics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.