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Clinical Outcomes Modeling for Laryngectomy Surgery Patients and Efficacy of Hyperbaric Oxygen Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Laryngeal Cancer

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Trial Information

Clinical Outcomes Modeling for Laryngectomy Surgery Patients and Efficacy of Hyperbaric Oxygen Therapy


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ara A. Chalian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinical Faculty, Dept. ORLHNS, University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

P50 AT000428-01P1

NCT ID:

NCT00026975

Start Date:

September 2000

Completion Date:

August 2005

Related Keywords:

  • Laryngeal Cancer
  • Laryngeal Cancer
  • Laryngectomy
  • Tissue Oxygenation
  • Irradiated Tissue
  • Hyperbaric Oxygen
  • Angiogenesis
  • EF5
  • Laryngeal Neoplasms

Name

Location

University of Pennsylvania Medical Center, Dept.of Otorhinolaryngology, 3400 Spruce Street, 5 RavdinPhiladelphia, Pennsylvania  19104