Hyperbaric Oxygen for Head and Neck Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether high-pressure oxygen treatment (Hyperbaric Oxygen Therapy) administered just before radiation therapy can help combat head and neck cancer. Researchers believe this approach might be effective based on past studies and an early trial. Participants will receive either the actual oxygen treatment or a placebo to compare results. The trial seeks individuals with advanced squamous cell carcinoma in specific areas, who are not candidates for surgery, and who do not have heart issues or distant cancer spread. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that hyperbaric oxygen therapy is likely to be safe for humans?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally safe for people with head and neck cancer. Studies have found that HBOT does not promote tumor growth or cause lasting changes in tumors. Researchers have tested its potential to enhance the effectiveness of radiation treatments for cancer in the head and neck area.

Results so far suggest that HBOT is well-tolerated, with most people experiencing no severe side effects. It has been used safely in other cancers, such as brain tumors, and reports indicate it may help with issues like dry mouth and other radiation-induced problems.

However, caution is advised for patients whose head and neck cancer has returned after treatment. Overall, HBOT appears to be a safe option for many undergoing cancer treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Most treatments for head and neck cancer, like surgery, radiation, and chemotherapy, focus on directly targeting and destroying cancer cells. But hyperbaric oxygen therapy works differently, enhancing the amount of oxygen in the blood, which can improve healing and potentially make cancer cells more sensitive to other treatments. Researchers are excited about this because increasing oxygen levels might also help reduce side effects and improve recovery times. Unlike traditional methods, this approach could offer a supportive treatment that enhances overall effectiveness and patient well-being.

What evidence suggests that hyperbaric oxygen might be an effective treatment for head and neck cancer?

This trial will compare hyperbaric oxygen therapy (HBOT) with a sham treatment for head and neck cancer. Research has shown that HBOT can benefit individuals with this condition. One study found that it improved symptoms after radiation, such as better mouth opening and reduced dry mouth. Another study showed that 75% of patients with head and neck issues experienced relief after HBOT. A Cochrane Review also found that HBOT is beneficial when combined with radiation therapy for this type of cancer. These findings suggest that HBOT might enhance the effects of radiation treatment for head and neck cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Richard E Clarke

Principal Investigator

National Baromedical Services

James R Hussey, PhD

Principal Investigator

University of South Carolina School of Public Health

James Wells, MD

Principal Investigator

Dorn Veterans Medical Center

Lindsie Cone, MD

Principal Investigator

Prisma Health Richland Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371294/

Radiation effects in head and neck and role of hyperbaric ... HBOT is found to be effective in improvement of post-radiation changes like mouth opening, xerostomia, discharge, foul smell, discharging sinus, etc.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03843671

Hyperbaric Radiation Sensitization of Head and Neck ... There is reason to believe that hyperbaric oxygen administered immediately prior to radiotherapy will prove beneficial for this cancer type and stage.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301604006534

The efficacy of hyperbaric oxygen therapy in the treatment ... Improvement of principal presenting symptoms after HBOT was noted in 75% of head-and-neck, 100% of pelvic, and 57% of “other” subjects (median duration of ...

4. oralcancerfoundation.org oralcancerfoundation.org/wp-content/uploads/2021/03/g24_0.pdf

Hyperbaric Oxygen Therapy for Head and Neck Irradiated ... 14 This study supports the efficacy of HBO therapy in reducing ORN. Based on all the available evidence, a recent Cochrane review concluded that HBO treatment ...

5. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02680-1

Hyperbaric oxygen therapy for late radiation tissue toxicity ... This review suggests that HBOT may be effective in the treatment of LRTTI in HNC patients. However, the supporting evidence is mainly derived ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943617/

Hyperbaric Oxygen Therapy for Managing Cancer Treatment ... Evaluations in head and neck tumor models revealed that HBOT did not promote tumor growth or induce lasting changes in the tumor ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301608039217

Hyperbaric Oxygen Therapy for Late Radiation-Associated ... Necrosis-rescuing HBOT should be used with caution in patients with locoregionally recurrent and then successfully salvaged head-and-neck cancers.