A phase I clinical trial of Hyperbaric Oxygen combined with radiation and chemotherapy for locally advanced squamous cell carcinoma of the head and neck
| ISRCTN | ISRCTN12244200 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12244200 |
| ClinicalTrials.gov number | NCT00474825 |
| Secondary identifying numbers | BRF 06-01 |
- Submission date
- 11/05/2007
- Registration date
- 22/05/2007
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Clarke
Scientific
Scientific
5 Richland Medical Park
Department of Hyperbaric Medicine
Columbia
South Carolina
29203
United States of America
| dick.clarke@palmettohealth.org |
Study information
| Study design | Multi-center, non-randomized clinical trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Hyperbaric oxygen as a radiation sensitizer for locally advanced squamous cell carcinoma of the head and neck: A phase I dose-escalation study. |
| Study acronym | HBO-XRT Phase I |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | hyperbaric oxygen |
| Primary outcome measure | 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 study start date | 07/01/2007 |
| Completion date | 02/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 9 to 18 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/01/2007 |
| Date of final enrolment | 02/01/2008 |
Locations
Countries of recruitment
- United States of America
Study participating centre
5 Richland Medical Park
South Carolina
29203
United States of America
29203
United States of America
Sponsor information
The Baromedical Research Foundation (USA)
Other
Other
9 Richland Medical Park
Suite No. 330
Columbia
South Carolina
29203
United States of America
| samir.desai@palmettohealth.org |
Funders
Funder type
Other
The Baromedical Research Foundation (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/05/2010 | 01/02/2019 | Yes | No |
Editorial Notes
01/02/2019: Publication reference added
