Hyperbaric Radiation Sensitization of Head and Neck Cancers

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Baromedical Services
• Collaborators: 59th Medical Wing; CISSS de Chaudière-Appalaches; Dartmouth-Hitchcock Medical Center; David Grant U.S. Air Force Medical Center; Hôtel-Dieu de Lévis; Mayo Clinic; Memorial Hermann Hospital; Prisma Health Richland Hospital; Wilford Hall Medical Center; William Jennings Bryan Dorn VA Medical Center

Criteria

Inclusion Criteria:

1. Patients with histological or microscopic proof (from the primary tumor and/or lymph nodes) of invasive squamous cell carcinoma of the oral cavity, oropharynx or larynx (World Health Organization type 1).

2. Stage III or IV disease, M0

3. Non-surgical candidate; for reasons of health or age (except biopsy)

4. Human Papillomavirus (P16) negative

5. Life expectancy of at least 6 months and a Karnofsky performance status of ≥ 70

6. Age ≥ 18 years

7. No distant metastatic disease

8. No clinically significant heart disease:

No significant ventricular arrhythmia requiring medication with antiarrhythmic. No symptomatic coronary artery disease (angina). No myocardial infarction within the last 6 months. No second or third degree heart block or bundle branch block or clinically significant conduction system abnormality.

9. Patients must sign a study-specific informed consent form

Exclusion Criteria:

1. Histology other than squamous cell carcinoma

2. Evidence of metastasis (below the clavicle or distant) by clinical or radiographic means

3. History of prior invasive malignancy, unless at least 5 years without evidence of recurrence (tumor-specific restaging)

4. Prior resection of the primary tumor or lymph node, unless un-operated N2-N3 nodal disease or primary tumor remaining, respectively.

5. Prior chemotherapy for head and neck cancer or radiotherapy to the head and neck

6. Prior treatment with Bleomycin

7. Creatinine clearance: measured or estimated Glomerular Filtration Rate <40 ml/min.

8. Patients with simultaneous primaries

9. Pregnancy

10. Participating in a conflicting protocol

11. Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma)

Current, untreated pneumothorax. Previous history of spontaneous pneumothorax. Previous history of intrathoracic surgery. History or evidence of pulmonary blebs or bullous lung disease. Clinically significant chronic obstructive pulmonary disease, associated with carbon dioxide retention, poorly controlled or associated with acute bronchospasm.

12. Where the hyperbaric physician deems the patient to have an otherwise unacceptable risk for hyperbaric chamber exposure

13. Claustrophobia