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Hyperbaric Oxygen for Head and Neck Cancer
Phase 2
Waitlist Available
Led By James Wells, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
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 moreTrial 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
Find a Location
Who is running the clinical trial?
National Baromedical ServicesLead Sponsor
2 Previous Clinical Trials
260 Total Patients Enrolled
Mayo ClinicOTHER
3,221 Previous Clinical Trials
3,768,740 Total Patients Enrolled
Dartmouth-Hitchcock Medical CenterOTHER
525 Previous Clinical Trials
2,540,399 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack in the last 6 months.I do not need medication for irregular heartbeats.I had cancer before, but it has not come back in over 5 years.I cannot undergo surgery due to my health or age.I have had surgery inside my chest before.I do not have lung conditions that increase my risk during pressure changes.I have previously been treated with Bleomycin.My cancer is not squamous cell carcinoma.I have a collapsed lung that hasn't been treated.I have a confirmed diagnosis of invasive squamous cell carcinoma in my mouth, throat, or voice box.My cancer has spread to areas below my collarbone or further.My doctor expects me to live at least 6 more months and I can care for myself.I have more than one primary cancer at the same time.I had surgery to remove my cancer or lymph nodes, unless I still have N2-N3 nodal disease or the primary tumor.I am 18 years old or older.I have had a collapsed lung in the past without injury.You are afraid of small, enclosed spaces.My kidney function is reduced, with a filtration rate under 40 ml/min.My cancer is not linked to the HPV virus.I have severe COPD with breathing issues or high CO2 levels.I have a history of lung blisters or bullous lung disease.My cancer has not spread to distant parts of my body.I have had chemotherapy or radiation for head and neck cancer.I do not have any major heart problems.I do not have chest pain from heart problems.My cancer is in stage III or IV but has not spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been identified in the use of Hyperbaric oxygen therapy?
"Based on the current evidence, Hyperbaric oxygen is estimated to be of a moderate safety rating (2) as it has yet to proceed through Phase 3 clinical trials and prove efficacy."
Answered by AI
Is this research initiative actively enrolling participants?
"Presently, clinicaltrials.gov fails to indicate that this investigation is actively seeking participants - the trial was originally made available on 7/1/2019 and last edited on 2/13/2019. Nevertheless, there are 2671 other trials recruiting right now."
Answered by AI
What outcomes is this experiment designed to generate?
"This two-year medical trial will measure its primary outcome, relapse free survival. Additionally, the secondary objectives include assessing subject quality of life by use of Functional Assessment for Cancer Therapy: Head and Neck version 4.0 and Performance Status Scale for Head and Neck; evaluating incidence and degree of late radiation tissue injury as outlined in Common Terminology Criteria Adverse Events version 5.0; measuring clinical assessment of acute hyperbaric complications such as ear/sinus barotrauma, oxygen toxicity, myopia, or confinement anxiety through their records evaluated by a hyperbaric physician."
Answered by AI
In what geographic regions can one access this clinical experiment?
"This clinical trial is now occurring at 5 distinct sites, located in Lévis, Rochester and Columbia as well as two other cities. It might be wise to pick the closest centre of these five to reduce travel demands if you choose to partake."
Answered by AI
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