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

NCT ID: NCT05913895

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-24

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head and Neck Cancer Oral Mucositis Pain Quality of Life

Keywords

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head and neck cancer hydrogen water cancer related symptom

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

hydrogen water

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

hydrogen water

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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boiled water

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chih-Jen Huang

Role: STUDY_CHAIR

Kaohsiung Medical University Chung-Ho Memorial Hospital

Locations

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUHIRB-F(I)-20230082

Identifier Type: -

Identifier Source: org_study_id