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Hyperbaric Oxygen for Head and Neck Cancer

Phase 2
Waitlist Available
Led By James R Hussey, PhD
Research Sponsored by National Baromedical Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No myocardial infarction within the last 6 months
No significant ventricular arrhythmia requiring medication with antiarrhythmic
Must not have
Previous history of intrathoracic surgery
Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years

Summary

This trial is testing whether oxygen therapy given before radiation treatment will help people with a certain type of cancer.

Who is the study for?
This trial is for adults over 18 with advanced stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, or larynx without distant metastasis. Candidates must not be surgical candidates due to health/age and should have a life expectancy of at least 6 months with good performance status. They cannot have significant heart disease, arrhythmia, recent myocardial infarction, severe kidney issues, other active cancers (unless cancer-free for 5 years), prior invasive malignancies in the area, claustrophobia or certain lung conditions.
What is being tested?
The study tests if hyperbaric oxygen therapy right before radiotherapy can improve treatment outcomes for head and neck cancers. It's based on previous research suggesting benefits from increased oxygen levels during radiation treatments.
What are the potential side effects?
Potential side effects may include ear pressure-related discomforts like middle ear barotrauma, sinus squeeze; temporary changes in vision; fatigue; and rare cases of decompression sickness which could cause joint pain and neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had a heart attack in the last 6 months.
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I do not need medication for irregular heartbeats.
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I cannot undergo surgery due to my health or age.
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I have a confirmed diagnosis of invasive squamous cell carcinoma in my mouth, throat, or voice box.
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My doctor expects me to live at least 6 more months and I can care for myself.
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I am 18 years old or older.
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My cancer is not linked to the HPV virus.
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My cancer has not spread to distant parts of my body.
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I do not have chest pain from heart problems.
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My cancer is in stage III or IV but has not spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery inside my chest before.
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I do not have lung conditions that increase my risk during pressure changes.
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I have previously been treated with Bleomycin.
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My cancer is not squamous cell carcinoma.
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I have a collapsed lung that hasn't been treated.
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My cancer has spread to areas below my collarbone or further.
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I have more than one primary cancer at the same time.
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I have had a collapsed lung in the past without injury.
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My kidney function is reduced, with a filtration rate under 40 ml/min.
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I have severe COPD with breathing issues or high CO2 levels.
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I have a history of lung blisters or bullous lung disease.
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I have had chemotherapy or radiation for head and neck cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival
Relapse free survival
Secondary study objectives
Hyperbaric protocol and radiotherapy dosing protocol compliance
Incidence and degree of acute radiation toxicity
Incidence and degree of late radiation tissue injury
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment2 Interventions
Hyperbaric oxygen Hyperbaric chamber
Group II: Group 2Placebo Group2 Interventions
Sham for hyperbaric oxygen Hyperbaric chamber
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric oxygen
2013
Completed Phase 4
~360
Hyperbaric chamber
2016
N/A
~50

Find a Location

Who is running the clinical trial?

National Baromedical ServicesLead Sponsor
2 Previous Clinical Trials
260 Total Patients Enrolled
Mayo ClinicOTHER
3,339 Previous Clinical Trials
3,061,745 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterOTHER
537 Previous Clinical Trials
2,539,316 Total Patients Enrolled

Media Library

Hyperbaric oxygen Clinical Trial Eligibility Overview. Trial Name: NCT03843671 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Group 1, Group 2
Squamous Cell Carcinoma Clinical Trial 2023: Hyperbaric oxygen Highlights & Side Effects. Trial Name: NCT03843671 — Phase 2
Hyperbaric oxygen 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843671 — Phase 2
~63 spots leftby Nov 2025
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