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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05913895
Collaborator
(none)
30
Enrollment
2
Arms
40
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hydrogen water
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of Hydrogen Water in Oral Mucositis, Oral Frailty, Pain and Quality of Life in Head and Neck Cancer Patients After Therapy
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
May 19, 2024
Anticipated Study Completion Date :
Oct 31, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [2 weeks]

      weight and height will be combined to report BMI in kg/m^2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

    • Study Chair: Chih-Jen Huang, Kaohsiung Medical University Chung-Ho Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT05913895
    Other Study ID Numbers:
    • KMUHIRB-F(I)-20230082
    First Posted:
    Jun 22, 2023
    Last Update Posted:
    Jun 22, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    head and neck cancer
    hydrogen water
    cancer related symptom
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Mucositis
    Stomatitis

    Study Results

    No Results Posted as of Jun 22, 2023