Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck (HBO-XRT)

February 3, 2012 updated by: Dick Clarke, National Baromedical Services

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • The Mayo Clinic
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Norfolk General Hospital / Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Hyperbaric Oxygen twice weekly (Monday & Friday) with Radiation and Chemotherapy
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
Drug: 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
Active Comparator: 2
Hyperbaric Oxygen three times per week (Monday, Wednesday & Friday) with Radiation and Chemotherapy.
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
Drug: 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
Active Comparator: 3
Hyperbaric Oxygen Five times per week (Monday through Friday) with Radiation and Chemotherapy
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
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient tolerance to each arm of the study
Time Frame: During intervention phase
During intervention phase

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade IV acute toxicities associated with each arm of the study
Time Frame: During intervention phase
During intervention phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Baromedical Services

Collaborators

Mayo Clinic
Dartmouth-Hitchcock Medical Center
Eastern Virginia Medical School
Prisma Health-Midlands

Investigators

  • Study Director: Dick Clarke, CHT, The Baromedical Research Foundation
  • Principal Investigator: Surjeet S Pohar, MD, Eastern Virginia Medical School / Norfolk General Hospital
  • Principal Investigator: Jay Buckey, MD, Dartmouth-Hitchcock Medical Center
  • Principal Investigator: Robert Foote, MD, The Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 17, 2007

Study Record Updates

Last Update Posted (Estimate)

February 6, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRF 06-01
  • ISRCTN12244200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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