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
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: Hydrogen Drug: Placebo oral tablet||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|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.|
|Official Title:||Pilot Study on Effects of Hydrogen Rich Water on Quality of Life of Patients Treated With Radiotherapy for High Grade Gliomas.|
|Actual Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||October 31, 2022|
|Estimated Study Completion Date :||October 31, 2023|
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.
Each hydrogen tablet contains 80 mg magnesium
Other Name: H2
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.
Drug: Placebo oral tablet
Matching placebo tablet also contains 80 mg magnesium
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175301
|Contact: Christine Pol, PhDfirstname.lastname@example.org|
|Contact: Agnieszka Kowalska, MDemail@example.com|
|United States, New York|
|Stony Brook University Medical Center||Recruiting|
|Stony Brook, New York, United States, 11794-8121|
|Contact: Christine Pol, PhD 631-444-9083 firstname.lastname@example.org|
|Contact: Agnieszka Kowalska, MD 631-444-2599 email@example.com|
|Sub-Investigator: Dennis Choi, MD, PhD|
|Sub-Investigator: Samuel Ryu, MD|
|Principal Investigator:||Agnieszka Kowalska, MD||Stony Brook Medicine|