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

Primary Purpose

Carcinoma, Squamous Cell, Cancer of the Head and Neck

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen

Hyperbaric oxygen

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Mayo Clinic
Dartmouth-Hitchcock Medical Center
Norfolk General Hospital / Eastern Virginia Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Patient tolerance to each arm of the study

Secondary Outcome Measures

Grade IV acute toxicities associated with each arm of the study

Full Information

NCT ID

NCT00474825

First Posted

May 16, 2007

Last Updated

February 3, 2012

Sponsor

National Baromedical Services

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00474825

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Baromedical Services

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Squamous Cell, Cancer of the Head and Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hyperbaric Oxygen Therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Hyperbaric Oxygen

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen

Intervention Description

Primary Outcome Measure Information:

Title

Patient tolerance to each arm of the study

Time Frame

During intervention phase

Secondary Outcome Measure Information:

Title

Grade IV acute toxicities associated with each arm of the study

Time Frame

During intervention phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dick Clarke, CHT

Organizational Affiliation

The Baromedical Research Foundation

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Surjeet S Pohar, MD

Organizational Affiliation

Eastern Virginia Medical School / Norfolk General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jay Buckey, MD

Organizational Affiliation

Dartmouth-Hitchcock Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Foote, MD

Organizational Affiliation

The Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Norfolk General Hospital / Eastern Virginia Medical School

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28126298

Citation

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.

Results Reference

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

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