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Dietary Supplement

Hydrogen-rich Water for Mucositis

N/A

Recruiting

Led By Kartik Mani, MD

Research Sponsored by Clare Moran

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of a biopsy proven head and neck cancer, early or advanced stage, primary or recurrent tumor

Planning to receive daily fractionated radiotherapy for over 4 weeks' duration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after completing radiation therapy

Awards & highlights

Study Summary

This trial looked at whether drinking hydrogen-rich water could help reduce mucositis, a common and painful side effect of radiation therapy for head and neck cancer.

Who is the study for?

This trial is for individuals with head and neck cancer, who are about to undergo daily radiotherapy for more than 4 weeks. Participants must be able to give consent, have a Karnofsky Performance Score of at least 70, swallow normally, and describe their pain.Check my eligibility

What is being tested?

The study is testing if drinking hydrogen-rich water can reduce mouth sores caused by radiation therapy in head and neck cancer patients. It compares the effects of regular water (control) with water containing dissolved hydrogen tablets.See study design

What are the potential side effects?

While not explicitly stated, potential side effects may include mild digestive discomfort or an unusual taste from the hydrogen tablets. Generally, hydrogen-rich water is considered safe with minimal risk of side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with head and neck cancer, at any stage.

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I am scheduled for daily radiotherapy for more than 4 weeks.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after completing radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after completing radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after completing radiation therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who develop grade 3 oropharyngeal mucositis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Group II: ControlPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Clare MoranLead Sponsor

Stony Brook UniversityLead Sponsor

216 Previous Clinical Trials

39,915 Total Patients Enrolled

DrinkHRWUNKNOWN

Media Library

Hydrogen tablets (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05278260 — N/A

Oral Mucositis Research Study Groups: Control, Active

Oral Mucositis Clinical Trial 2023: Hydrogen tablets Highlights & Side Effects. Trial Name: NCT05278260 — N/A

Hydrogen tablets (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05278260 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being enrolled in this investigation?

"Correct. Reports on clinicaltrials.gov suggest that this medical study, which was first registered on May 25th 2022, is actively recruiting patients. A total of 56 individuals need to be enlisted from a single site."

Answered by AI

Are there any openings for participants in this trial?

"Indeed, clinicaltrials.gov indicates that this medical trial is still recruiting participants after being launched on May 25th 2022 and last updated on June 15th 2022. 56 patients are needed to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients

Clare Moran 2022. "Hydrogen-rich Water and Treatment of Mucositis Caused by Radiation Therapy in Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05278260.

All > Radiotherapy