The Effect of Hydrogen Water in Oral Mucositis 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Oral Mucositis Pain Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Stomatitis Stomatognathic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

hydrogen water

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2026
First posted: Jun 22, 2023
Registry last updated: Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting