Condition category
Cancer
Date applied
11/05/2007
Date assigned
22/05/2007
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Richard Clarke

ORCID ID

Contact details

5 Richland Medical Park
Department of Hyperbaric Medicine
Columbia
South Carolina
29203
United States of America
dick.clarke@palmettohealth.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00474825

Protocol/serial number

BRF 06-01

Study information

Scientific title

Acronym

HBO-XRT Phase I

Study hypothesis

This research is carried out as 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 hope of generating greater results in killing cancer cells.

This study has two main objectives:
1. To determine patient tolerance to increasing dose of HyperBaric Oxygen (HBO) therapy
2. To determine the feasibility of treatment delivery and acute toxicities associated with each regimen

Ethics approval

1. Norfolk General Hospital / Eastern Virginia Medical School - Office of Research Subjects Proctections Institutional Review Board (IRB), approved on 18 April 2007. Ref: 07-02-FB-0045

IRB review ongoing for three centers as of 22/05/2007:
2. The Mayo Clinic (Minnesota, USA)
3. Darthmouth-Hitchcock Medical Center (New Hampshire, USA)
4. Palmetto Health Richland (South Carolina, USA)

Study design

Multi-center, non-randomized clinical trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Locally advanced squamous cell carcinoma of the head and neck.

Intervention

HBO therapy in conjunction with standard care (chemotherapy and radiation therapy). Each HBO session will last for 30 minutes. There are 3 arms in this intervention, each with a different HBO dosage per week.

The first 3 patients will receive HBO twice a week (Monday and Friday) for 7 weeks (Arm 1). If no adverse event is reported, another set of 3 patients will receive HBO three times a week (Monday, Wednesday and Friday) for 7 weeks (Arm 2). Again, if no adverse event is observed, a final set of 3 patients will receive HBO five times a week (Monday through Friday) for 7 weeks (Arm 3).

In case an adverse event is reported in any of the three arms, another set of 3 patients will be randomized in the same arm to see if the events are repeated.

Intervention type

Drug

Phase

Phase I

Drug names

hyperbaric oxygen

Primary outcome measures

Patient tolerance to each arm of the trial during the treatment, determined by the occurrence of Grade IV acute toxicity using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

Secondary outcome measures

1. Feasibility of treatment delivery
2. Acute toxicities associated with each regimen
3. Quality of life, assessed by the following:
3.1. The Functional Assessment of Cancer Therapy (FACT) - Head and Neck Cancer, assessed at pre-treatment and then at 6 months, 1 year and 2 years after completing treatment
3.2. The Performance Status Scale (PSS) for Head and Neck cancer, assessed at pre-treatment, during the last two weeks of treatment, and then at 3 months, 1 year and 2 years after completing treatment

Overall trial start date

07/01/2007

Overall trial end date

02/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx
2. Stage III or IV, M0 squamous cell carcinoma
3. Life expectancy of at least 6 months and a Karnofsky performance status of ≥ 70
4. Age ≥ 18 years and ≤ 70 years
5. Patients must sign a study-specific informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

9 to 18

Participant exclusion criteria

1. Histology other squamous cell carcinoma
2. Evidence of metastasis (below the clavicle or distant) by clinical or radiographic means
3. Previous complete resection of the primary tumor
4. Previous chemotherapy (Bleomycin) for head and neck cancer or radiotherapy to the head and neck
5. Patients with simultaneous primaries
6. Pregnancy
7. Pulmonary pathologies (risk of decompression-induced pulmonary barotrauma):
7.1. Current, untreated pneumothorax
7.2. History of pneumothorax
7.3. History of intrathoracic surgery
7.4. History of pulmonary blebs or bullous lung disease
7.5. Associated with CO2 retention
7.6. Poorly controlled or associated with acute bronchospasm
8. Clinically significant heart diseases:
8.1. Significant ventricular arrhythmia requiring medication with antiarrhythmics
8.2. Symptomatic coronary artery disease (angina)
8.3. Myocardial infarction within the last 6 months
8.4. Second or third degree heart block or bundle branch block or clinically significant conduction system abnormality
9. Where the hyperbaric physician deems the patient to have an unacceptable risk for hyperbaric treatments
10. Claustrophobia

Recruitment start date

07/01/2007

Recruitment end date

02/01/2008

Locations

Countries of recruitment

United States of America

Trial participating centre

5 Richland Medical Park
South Carolina
29203
United States of America

Sponsor information

Organisation

The Baromedical Research Foundation (USA)

Sponsor details

9 Richland Medical Park
Suite No. 330
Columbia
South Carolina
29203
United States of America
samir.desai@palmettohealth.org

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

The Baromedical Research Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes