Carcinoma, Squamous CellPhase 1HBO-XRTNCT00474825

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

A Phase 1 study testing Hyperbaric Oxygen Therapy and Hyperbaric Oxygen in people with Carcinoma, Squamous Cell and Cancer of the Head and Neck, run by National Baromedical Services at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Carcinoma, Squamous Cell, Cancer of the Head and Neck
What is being tested?: Hyperbaric Oxygen Therapy and Hyperbaric Oxygen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 3 sitesUnited States
Study dates: Jul 2007to Feb 2011
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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

Who cannot join

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

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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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Carcinoma, Squamous Cell, Cancer of the Head and Neck
Being tested: Hyperbaric Oxygen Therapy, Hyperbaric Oxygen
Medical subject headings: Carcinoma, Squamous Cell, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyperbaric Oxygen TherapyDrug
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 OxygenDrug
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 oxygenDrug
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 oxygenDrug
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

Study groups in NCT00474825
Study group	Role	What they receive
1	Active comparator	Hyperbaric Oxygen twice weekly (Monday \& Friday) with Radiation and Chemotherapy Receives: Drug: Hyperbaric Oxygen Therapy; Drug: Hyperbaric Oxygen
2	Active comparator	Hyperbaric Oxygen three times per week (Monday, Wednesday \& Friday) with Radiation and Chemotherapy. Receives: Drug: Hyperbaric Oxygen Therapy; Drug: Hyperbaric oxygen
3	Active comparator	Hyperbaric Oxygen Five times per week (Monday through Friday) with Radiation and Chemotherapy Receives: Drug: Hyperbaric Oxygen Therapy; Drug: Hyperbaric oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient tolerance to each arm of the study
Measured: During intervention phase

Secondary outcomes (1)

Grade IV acute toxicities associated with each arm of the study
Measured: During intervention phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2007Feb 2011

First posted17 May 2007 (estimated)
Study startJul 2007
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00474825
Sponsor's protocol ID: BRF 06-01
Other IDs: ISRCTN12244200
Acronym: HBO-XRT
Status last verified: Feb 2012
First submitted: 16 May 2007
Last updated: 6 Feb 2012
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 28126298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Squamous Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00474825
Acronym / sponsor ID: HBO-XRT / BRF 06-01
Conditions: Carcinoma, Squamous Cell, Cancer of the Head and Neck
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: National Baromedical ServicesUniversity, hospital or other
Collaborators: Prisma Health-Midlands, Mayo Clinic, Dartmouth-Hitchcock Medical Center, Eastern Virginia Medical School
Study start: Jul 2007
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 17 May 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: Hyperbaric Oxygen Therapy, Drug: Hyperbaric OxygenHyperbaric Oxygen twice weekly (Monday \& Friday) with Radiation and Chemotherapy
2	Active comparator	Drug: Hyperbaric Oxygen Therapy, Drug: Hyperbaric oxygenHyperbaric Oxygen three times per week (Monday, Wednesday \& Friday) with Radiation and Chemotherapy.
3	Active comparator	Drug: Hyperbaric Oxygen Therapy, Drug: Hyperbaric oxygenHyperbaric Oxygen Five times per week (Monday through Friday) with Radiation and Chemotherapy

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyperbaric Oxygen TherapyCompression 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	1, 2, 3
Hyperbaric OxygenCompression 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	1
Hyperbaric oxygenCompression 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	2
Hyperbaric oxygenCompression 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	3

Primary outcome

Patient tolerance to each arm of the study
Time frame: During intervention phase

1 secondary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2012.
Background: PubMed 28126298Hartford 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.

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Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dick Clarke, CHT study director

The Baromedical Research Foundation

Surjeet S Pohar, MD principal investigator

Eastern Virginia Medical School / Norfolk General Hospital

Jay Buckey, MD principal investigator

Dartmouth-Hitchcock Medical Center

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient tolerance to each arm of the study (time frame: During intervention phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00474825, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2012.