Hydrogen inhalation therapy for head and neck cancer patients

ROLE OF HYDROGEN INHALATION THERAPY IN REDUCING ACUTE TOXICITIES OF TREATMENT IN HEAD AND NECK CANCERS

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/03/051034

Enrollment

Registered

2023-03-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C760- Malignant neoplasm of head, face and neck

Interventions

Intervention1: serene envirotech solutions pvt.ltd: udazh inhaler Intervention2: Nil: Nil Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 1.All patients with primary head and neck cancer treated with concurrent chemo radiation between February 2023 to February 2024 2.Patients belonging to all age groups, both male and females were included

Exclusion criteria

Exclusion criteria: 1. Patients with Stage IV disease 2.Patients receiving palliative radiation 3.Patients with recurrent head and neck cancers on re radiation 4.Immune compromised patients and those with auto immune diseases. 5.Patients with any other disease or condition that may add to the toxicity

Design outcomes

Primary

Measure	Time frame
Primary objective 1.To find out if hydrogen inhalation therapy given along with concurrent chemoradiation in patients with head and neck cancer help in reducing toxicities such as mucositis and hematological toxicity Secondary Objective 1 To identify the role of hydrogen inhalation therapy in improving quality of life in patients with head and neck cancer undergoing radiation therapy STUDY TYPE: Phase II Prospective observational study STUDY DURATION: 1 year (February 2023 to February 2024) STUDY POPULATION: All patients with primary head and neck cancers treated with concurrent chemoradiation in our hospital during February 2023 to February 2024 SAMPLE SIZE: 37 patients in each arm (Hydrogen arm and without hydrogen arm) Timepoint: Primary objective 1.To find out if hydrogen inhalation therapy given along with concurrent chemoradiation in patients with head and neck cancer help in reducing toxicities such as mucositis and hematological toxicity Secondary Objective 1 To identify the role of hydrogen inhalation therapy in improving quality of life in patients with head and neck cancer undergoing radiation therapy STUDY TYPE: Phase II Prospective observational study STUDY DURATION: 1 year (February 2023 to February 2024) STUDY POPULATION: All patients with primary head and neck cancers treated with concurrent chemoradiation in our hospital during February 2023 to February 2024 SAMPLE SIZE: 37 patients in each arm (Hydrogen arm and without hydrogen arm)	—

Measure

Time frame

Primary objective 1.To find out if hydrogen inhalation therapy given along with concurrent chemoradiation in patients with head and neck cancer help in reducing toxicities such as mucositis and hematological toxicity Secondary Objective 1 To identify the role of hydrogen inhalation therapy in improving quality of life in patients with head and neck cancer undergoing radiation therapy STUDY TYPE: Phase II Prospective observational study STUDY DURATION: 1 year (February 2023 to February 2024) STUDY POPULATION: All patients with primary head and neck cancers treated with concurrent chemoradiation in our hospital during February 2023 to February 2024 SAMPLE SIZE: 37 patients in each arm (Hydrogen arm and without hydrogen arm) Timepoint: Primary objective 1.To find out if hydrogen inhalation therapy given along with concurrent chemoradiation in patients with head and neck cancer help in reducing toxicities such as mucositis and hematological toxicity Secondary Objective 1 To identify the role of hydrogen inhalation therapy in improving quality of life in patients with head and neck cancer undergoing radiation therapy STUDY TYPE: Phase II Prospective observational study STUDY DURATION: 1 year (February 2023 to February 2024) STUDY POPULATION: All patients with primary head and neck cancers treated with concurrent chemoradiation in our hospital during February 2023 to February 2024 SAMPLE SIZE: 37 patients in each arm (Hydrogen arm and without hydrogen arm)

—

Secondary

Measure	Time frame
Secondary Objective 1 To identify the role of hydrogen inhalation therapy in improving quality of life in patients with head and neck cancer undergoing radiation therapyTimepoint: 1 month	—

Countries

India

Contacts

Public ContactDrGGovindaraj

Harshamitra Super Speciality Cancer Center and Research Institute

govindarajganesan@gmail.com7373542777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026