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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

30

Phase

  • 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 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

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
Intervention / Treatment
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

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

Kaohsiung Medical University Chung-Ho Memorial Hospital

Investigators

  • 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)

December 24, 2023

Primary Completion (Estimated)

May 19, 2024

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

June 4, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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