Hyperbaric Oxygen for Head and Neck Cancer

Recruiting at 4 trial locations

Overseen By Richard E Clarke

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Baromedical Services

Must not be taking: Antiarrhythmics, Bleomycin

Disqualifiers: Metastasis, Prior malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 37

Duration: 7 weeks

400 Participants Needed

Trial Summary

What is the purpose of this trial?

There is reason to believe that hyperbaric oxygen administered immediately prior to radiotherapy will prove beneficial for this cancer type and stage. The basis for this hypothesis is a review of several decades of published work, the conclusion of a recent (2018) Cochrane Review, and results of a Phase I trial.

Research Team

James R Hussey, PhD

Principal Investigator

University of South Carolina School of Public Health

Richard E Clarke

Principal Investigator

National Baromedical Services

James Wells, MD

Principal Investigator

Dorn Veterans Medical Center

Lindsie Cone, MD

Principal Investigator

Prisma Health Richland Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have not had a heart attack in the last 6 months.

I do not need medication for irregular heartbeats.

I cannot undergo surgery due to my health or age.

Exclusion Criteria

Participating in a conflicting protocol

I had cancer before, but it has not come back in over 5 years.

I have had surgery inside my chest before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperbaric oxygen therapy immediately prior to radiotherapy for head and neck squamous cell carcinoma

7 weeks

35 hyperbaric chamber exposures, 35 radiotherapy treatments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Regular assessments at 2 weeks post RT, then 3, 6, 12, and 24 months post radiotherapy

Treatment Details

Interventions

• Hyperbaric Oxygen

Trial Overview 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.

Participant Groups

Group I: Group 1 Experimental Treatment 2 Interventions

Hyperbaric oxygen Hyperbaric chamber

Group II: Group 2 Placebo Group 2 Interventions

Sham for hyperbaric oxygen Hyperbaric chamber

Who Is Running the Clinical Trial?

National Baromedical Services

Lead Sponsor

Trials

3

Recruited

660+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

CISSS de Chaudière-Appalaches

Collaborator

Trials

9

Recruited

16,500+

Memorial Hermann Hospital

Collaborator

Trials

17

Recruited

56,300+

David Grant U.S. Air Force Medical Center

Collaborator

Trials

30

Recruited

2,300+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

Prisma Health Richland Hospital

Collaborator

Trials

1

Recruited

400+

William Jennings Bryan Dorn VA Medical Center

Collaborator

Trials

6

Recruited

1,900+