Hyperbaric Oxygen for Head and Neck Cancer
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.12345Why 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.13467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hyperbaric oxygen therapy immediately prior to radiotherapy for head and neck squamous cell carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Placebo Group
Hyperbaric oxygen Hyperbaric chamber
Sham for hyperbaric oxygen Hyperbaric chamber
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Baromedical Services
Lead Sponsor
Mayo Clinic
Collaborator
Dartmouth-Hitchcock Medical Center
Collaborator
CISSS de Chaudière-Appalaches
Collaborator
Memorial Hermann Hospital
Collaborator
David Grant U.S. Air Force Medical Center
Collaborator
59th Medical Wing
Collaborator
Prisma Health Richland Hospital
Collaborator
William Jennings Bryan Dorn VA Medical Center
Collaborator
Citations
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.
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.
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 ...
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 ...
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 ...
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 ...
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.
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