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Hyperbaric Oxygen for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Lindsie Cone, MD

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

Awards & highlights

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression free survival

Relapse free survival

Secondary outcome measures

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

~280

Hyperbaric chamber

2016

N/A

~50

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Baromedical ServicesLead Sponsor

2 Previous Clinical Trials

260 Total Patients Enrolled

Mayo ClinicOTHER

3,255 Previous Clinical Trials

3,835,006 Total Patients Enrolled

Dartmouth-Hitchcock Medical CenterOTHER

530 Previous Clinical Trials

2,544,534 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

~67 spots leftby Jul 2025

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