- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00026975
Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients
Clinical Outcomes Modeling for Laryngectomy Surgery Patients and Efficacy of Hyperbaric Oxygen Therapy
Study Overview
Detailed Description
Clinical Outcomes Modeling for Laryngectomy Surgery Patients and Efficacy of Hyperbaric Oxygen Therapy, with Ara Chalian, MD as Project Leader, will develop a predictive model for surgical risk among patients requiring laryngectomy due to cancer, validate the model and assess the efficacy of HB02 therapy for improving outcome. The focus will be to determine the patho-physiological basis for heightened surgical risk among post-radiation head and neck patients and the efficacy of hyperbaric oxygen (HB02) therapy for improving outcome.
This multidisciplinary center will investigate the mechanisms of action, safety, and clinical efficacy of Hyperbaric Oxygen (HB02) Therapy. The group will evaluate if HB02 therapy will benefit patients who must undergo laryngectomy and reconstructive surgery after radiation therapy because, at pharmacological doses, oxygen augments angiogenesis and impedes specific types of intercellular adherence.
The project tests two hypotheses: (1) Predictive models can be developed for sub-groups of head and neck cancer patients who have undergone surgery based on tumor specific site, previous treatment, and co-morbidity and predict which patients will have complications (wound infection and fistula), and (2) HB02 given by a standard protocol can modify tissue hypoxia and vascularity that is present in patients with previous radiation therapy to the neck who have recurrent or secondary cancers requiring laryngectomy. The specific aims are to: (1) develop a detailed database model to predict the risk of developing post-operative complications in complex head and neck aerodigestive tract cancer resections, (2) conduct prospective validation of the predictive model using data on patients treated at the University of Pennsylvania Head and Neck Cancer Center, (3) determine whether hyperbaric oxygen therapy alters post-surgical complication rates and acute and long-term quality of life. The studies include evaluation of clinical parameters, surgical outcome and quality of life measurements, and objective, laboratory-based assessments of the magnitude of hypoxia/vascularization in surgical zones and tumors to provide objective data on surgical risk and clinical responses to HB02 therapy.
The prospective trial allows for planned follow-up and data collection for modeling and tumor oxygenation assessments for patients undergoing laryngectomy. The randomized trial is a treatment trial, comparing standard care before and after laryngectomy to the intervention of pre- & post-operative HBO2 in conjunction with laryngectomy. All patients receive nutritional counseling, speech therapy, and comprehensive peri-surgical care.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Medical Center, Dept.of Otorhinolaryngology, 3400 Spruce Street, 5 Ravdin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Prospective Trial:
- a lesion either suspicious for or diagnosed by biopsy as laryngeal/adjacent pharyngeal cancer requiring a total or partial laryngectomy, or if previously irradiated and ineligible for the randomized trial.
- no history of radiation to the head/neck
- adequate liver and kidney function
- no plans to become pregnant or conceive for the duration of the study
Inclusion Criteria for Randomized Trial:
- have been previously irradiated for a head/neck cancer requiring a total laryngectomy
- demonstrate a lesion either suspicious for or diagnosed by biopsy as laryngeal/adjacent pharyngeal cancer
- have adequate liver and kidney function
- meet physical requirements for hyperbaric oxygen therapy
- agree to randomization of care to receive a laryngectomy and standard follow-up care vs. hyperbaric oxygen therapy preoperatively and postoperatively
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Principal Investigator: Ara A. Chalian, MD, Clinical Faculty, Dept. ORLHNS, University of Pennsylvania
- Study Director: Stephen R. Thom, MD PhD, Chief of Section, Dept. of Hyperbaric Medicine, University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50AT000428-01P1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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