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

NCT00474825 | Completed Phase 1 DMC

• 2 other identifiers: BRF 06-01ISRCTN12244200
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Carcinoma, Squamous Cell; Cancer of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Patient tolerance to each arm of the study

  During intervention phase

Secondary Outcomes (1)

• Grade IV acute toxicities associated with each arm of the study

  During intervention phase

Study Arms (3)

1

ACTIVE COMPARATOR

Hyperbaric Oxygen twice weekly (Monday \& Friday) with Radiation and Chemotherapy

Drug: Hyperbaric Oxygen Therapy; Drug: Hyperbaric Oxygen

2

ACTIVE COMPARATOR

Hyperbaric Oxygen three times per week (Monday, Wednesday \& Friday) with Radiation and Chemotherapy.

Drug: Hyperbaric Oxygen Therapy; Drug: Hyperbaric oxygen

3

ACTIVE COMPARATOR

Hyperbaric Oxygen Five times per week (Monday through Friday) with Radiation and Chemotherapy

Drug: Hyperbaric Oxygen Therapy; Drug: Hyperbaric oxygen

Interventions

Hyperbaric Oxygen Therapy DRUG

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

1; 2; 3

Hyperbaric oxygen DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Baromedical Services: lead
• Prisma Health-Midlands: collaborator
• Mayo Clinic: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Eastern Virginia Medical School: collaborator

Study Sites (3)

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Norfolk General Hospital / Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• Hartford AC, Davis TH, Buckey JC, Foote RL, Sinesi MS, Williams BB, Fariss AK, Schaner PE, Claus PL, Okuno SH, Hussey JR, Clarke RE. Hyperbaric Oxygen as Radiation Sensitizer for Locally Advanced Squamous Cell Carcinoma of the Oropharynx: A Phase 1 Dose-Escalation Study. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):481-486. doi: 10.1016/j.ijrobp.2016.10.048. Epub 2016 Nov 15.

  PMID: 28126298 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Dick Clarke, CHT

  The Baromedical Research Foundation

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, National Baromedical Research Foundation

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 17, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

US (3)