Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck

Completed · Phase 1

Conditions studied: Carcinoma, Squamous Cell, Cancer of the Head and Neck

In brief

This research is being done because we do not know the best treatment for advanced Squamous Cell Carcinoma of the Head and Neck. These cancers have been treated with a combination of surgery, radiation and chemotherapy in varying combination. When the tumor is inoperable, radiation therapy is used with or without chemotherapy in the hope of curing the tumor. Recently, it has become recognized as generalized knowledge that cancer cells are hypoxic (low oxygen concentration). Because of the low oxygen concentrations, many cancer treatments have not been successful. The theory behind this study is to give oxygen to patients prior to chemotherapy and radiation in hopes of generating greater results in killing cancer cells. The purpose of this study has two main objectives. The primary objective is to determine patient tolerance to each arm of the trial. The second objective is to determine the feasibility of treatment delivery and acute toxicities associated with each regimen. It is our intention to undertake a randomized and controlled trial should this Phase I trial prove successful in terms of patient tolerance.

Key facts

Study ID

NCT00474825

Run by

National Baromedical Services

People needed

12

Starts

2007-07-01

Expected to finish

2011-02-01

Last updated by the study team

2012-02-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
• Patients should have Stage III or IV disease, M0
• Patients must have life expectancy of at least 6 months and a Karnofsky performance status of ≥ 70
• Age ≥ 18 years and ≤ 70 years
• No distant metastatic disease
• No clinically significant heart disease:
• No significant ventricular arrhythmia requiring medication with antiarrhythmics
• 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

You may not qualify if…

• Histology other than squamous cell carcinoma
• Evidence of metastasis (below the clavicle or distant) by clinical or radiographic means
• Prior complete resection of the primary tumor
• Prior chemotherapy (Bleomycin) for head and neck cancer or radiotherapy to the head and neck
• Patients with simultaneous primaries
• Pregnancy
• Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma):
• Current, untreated pneumothorax
• Previous history of pneumothorax
• Previous history of intrathoracic surgery
• History of pulmonary blebs or bullous lung disease
• Associated with CO2 retention
• Poorly controlled or associated with acute bronchospasm
• Where the hyperbaric physician deems the patient to have an unacceptable risk for hyperbaric treatments
• Claustrophobia

Where it is running

• The Mayo Clinic — Rochester, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Norfolk General Hospital / Eastern Virginia Medical School — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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