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

Carcinoma, Squamous Cell Clinical Trial

— HBO-XRT  

Official title:

Phase I Clinical Trial of Hyperbaric Oxygen Combined With Radiation and Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474825
• Other study ID #: BRF 06-01
• Secondary ID: ISRCTN12244200
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2007
• Last updated: February 3, 2012
• Start date: July 2007
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Baromedical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The goal of this study is to see if patients can tolerate HBO therapy up to five days a week.

Three patients in Arm 1 (HBO on Monday and Friday) will be observed throughout their course of concomitant radiation, chemo and hyperbaric therapy. If these patients appear to tolerate this protocol well, and no adverse effects that can be directly attributed to HBO are observed, then three more patients will be recruited for Arm 2 (HBO on Monday, Wednesday, and Friday). If again these patients appear to tolerate this protocol well, and no adverse effects that can be directly attributed to HBO are observed, then a third group of three patients will be recruited for Arm 3 (HBO Monday through Friday).

If Grade IV acute toxicity is reported for a single patient in any of the arms, 3 more patients will be recruited in the same arm. If no further adverse events occur, the protocol progresses to the next arm. If Grade IV acute toxicity is observed even a single patient, the study will be stopped.

Tumor and/or lymphatic tissue specimens will be obtained prior to starting treatment. Tumor tissue specimens will be analyzed to determine whether there is a predictive susceptibility of tumors to HBO sensitization using currently defined biomarkers known to correlate with survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Head and Neck
• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms

Intervention

Drug:
• Hyperbaric Oxygen Therapy
Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
• Hyperbaric Oxygen
Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
• Hyperbaric oxygen
Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute
• Hyperbaric oxygen
Compression rate (breathing oxygen): per patient tolerance; 1 - 3 psi per minute Treatment dose: 2.4 ATA oxygen Treatment period: 30 minutes at 2.4 ATA Decompression rate (breathing oxygen): 2 - 3 psi per minute

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Norfolk General Hospital / Eastern Virginia Medical School	Norfolk	Virginia
United States	The Mayo Clinic	Rochester	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
Baromedical Research Foundation	Dartmouth-Hitchcock Medical Center, Eastern Virginia Medical School, Mayo Clinic, Palmetto Health Richland

Country where clinical trial is conducted

United States, 

References & Publications (1)

R.E. Clarke, T.H. Davis, R.L. Foote, et al. Hyperbaric oxygen as a radiation sensitizer for locally advanced squamous cell carcinoma of the head and neck: A phase I dose-escalation study. J Clin Oncol 28, 2010 (suppl; abstr e16002)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient tolerance to each arm of the study		During intervention phase	No
Secondary	Grade IV acute toxicities associated with each arm of the study		During intervention phase	No