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

NCT05913895 | Active Not Recruiting

• 1 other identifier: KMUHIRB-F(I)-20230082
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Oral Mucositis; Pain; Quality of Life

Keywords

head and neck cancer; hydrogen water; cancer related symptom

Outcome Measures

Primary Outcomes (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

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

  2 weeks

Study Arms (2)

hydrogen water

EXPERIMENTAL

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

boiled water

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: boiled water

boiled water; hydrogen water

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 807, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis; Pain

Interventions

Water

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Chih-Jen Huang

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 22, 2023
• Study Start: December 24, 2023
• Primary Completion: May 19, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 27, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)