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