Status:
UNKNOWN
Hyperbaric Radiation Sensitization of Head and Neck Cancers
Lead Sponsor:
National Baromedical Services
Collaborating Sponsors:
Mayo Clinic
Dartmouth-Hitchcock Medical Center
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 seve...
Detailed Description
The goal of this research is to address the question: "Does the addition of hyperbaric oxygen to radiation and chemotherapy improve outcomes in locally advanced oropharyngeal or laryngeal squamous ce...
Eligibility Criteria
Inclusion
- 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).
- Stage III or IV disease, M0
- Non-surgical candidate; for reasons of health or age (except biopsy)
- Human Papillomavirus (P16) negative
- Life expectancy of at least 6 months and a Karnofsky performance status of ≥ 70
- Age ≥ 18 years
- No distant metastatic disease
- 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.
- Patients must sign a study-specific informed consent form
Exclusion
- Histology other than squamous cell carcinoma
- Evidence of metastasis (below the clavicle or distant) by clinical or radiographic means
- History of prior invasive malignancy, unless at least 5 years without evidence of recurrence (tumor-specific restaging)
- Prior resection of the primary tumor or lymph node, unless un-operated N2-N3 nodal disease or primary tumor remaining, respectively.
- Prior chemotherapy for head and neck cancer or radiotherapy to the head and neck
- Prior treatment with Bleomycin
- Creatinine clearance: measured or estimated Glomerular Filtration Rate \<40 ml/min.
- Patients with simultaneous primaries
- Pregnancy
- Participating in a conflicting protocol
- 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.
- Where the hyperbaric physician deems the patient to have an otherwise unacceptable risk for hyperbaric chamber exposure
- Claustrophobia
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03843671
Start Date
July 1 2019
End Date
December 31 2024
Last Update
February 18 2019
Active Locations (5)
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1
The Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
4
Wilford Hall Medical Facility
San Antonio, Texas, United States, 78236