The Effect of Hydrogen Water in Oral Mucositis in Head and Neck Cancer Patients After Therapy

December 24, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

The Effect of Hydrogen Water in Oral Mucositis, Oral Frailty, Pain and Quality of Life in Head and Neck Cancer Patients After Therapy

Inpatients or outpatients diagnosed with head and neck cancer who met the inclusion and exclusion criteria were referred to the co-investigator(Dr. Chih-Jen Huang and Dr. Hui-Ching Wang), who then personally explained to each participant, the purpose and conduct of the study, so that they all understood their rights and interests before giving a written consent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study design was a randomized controlled trial and a longitudinal study with structured questionnaires (17-question basic information questionnaire、 The World Health Organization scale, WHO、NCI-CTCAE V5.0、Brief Pain Inventory-Taiwan、oral frailty checklist、European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head & neck). The participants were randomly assigned to the experimental group (gargling with hydrogen water) and the control group (gargling with boiled water) by block randomization through a questionnaire administered by the investigator. At the end of cancer treatment (chemotherapy, radiotherapy, or Chemoradiotherapy), a hydrogen water gargle (dissolved for 12 hours or longer) or boiled water gargle was administered by the investigator or a researcher every Monday through Friday. The changes in six scales described above were tracked in the experimental and control groups on days 1 (T1), 3 (T2), 7 (T3), and 14 (T4) after the end of treatment. The data from these scales were entered into a computer and analyzed using statistical software, and the overall data are presented to demonstrate the efficacy of hydrogen water.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Sanmin Dist
      • Kaohsiung, Sanmin Dist, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. pathological diagnosed with head and neck cancer
  2. adults over the age of 20
  3. have normal cognition
  4. can use Mandarin or Taiwanese to communicate
  5. received radiation therapy or combined chemotherapy

Exclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status 2, 3 and 4
  2. received oral cancer surgery within two months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: hydrogen water
At the end of cancer treatment (chemotherapy, radiotherapy, or Chemoradiotherapy), a hydrogen water gargle (dissolved for 12 hours or longer) was administered by the investigator or a researcher every Monday through Friday. The changes in six scales described above were tracked in the experimental and control groups on days 1 (T1), 3 (T2), 7 (T3), and 14 (T4) after the end of treatment.
Other: hydrogen water
To investigate whether the intervention of hydrogen water adjuvant therapy can improve oral mucositis, oral frailty, pain and Quality of Life with head and neck cancer who have received radiation therapy or combined chemotherapy.
Other Names:
  • boiled water
Placebo Comparator: boiled water
At the end of cancer treatment (chemotherapy, radiotherapy, or Chemoradiotherapy),boiled water gargle was administered by the investigator or a researcher every Monday through Friday. The changes in six scales described above were tracked in the experimental and control groups on days 1 (T1), 3 (T2), 7 (T3), and 14 (T4) after the end of treatment.
Other: hydrogen water
To investigate whether the intervention of hydrogen water adjuvant therapy can improve oral mucositis, oral frailty, pain and Quality of Life with head and neck cancer who have received radiation therapy or combined chemotherapy.
Other Names:
  • boiled water

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0,Change From Baseline in Pain Scores on the Brief Pain Inventory-Taiwan Scale at 2 Weeks
Time Frame: 2 weeks
weight and height will be combined to report BMI in kg/m^2
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chih-Jen Huang, Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 24, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-F(I)-20230082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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