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Trial Title:
The Effect of Hydrogen Water in Oral Mucositis in Head and Neck Cancer Patients After Therapy
NCT ID:
NCT05913895
Condition:
Head and Neck Cancer
Oral Mucositis
Pain
Quality of Life
Conditions: Official terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Conditions: Keywords:
head and neck cancer
hydrogen water
cancer related symptom
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
hydrogen water
Description:
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.
Arm group label:
boiled water
Arm group label:
hydrogen water
Other name:
boiled water
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Start date:
December 24, 2023
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Agency class:
Other
Source:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05913895
