Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients

NCT00026975 | Completed Phase 2

• 1 other identifier: P50AT000428-01P1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to develop a predictive model for the development of wound complications in patients undergoing laryngectomy surgery for laryngeal/adjoining structure cancers, and to evaluate the clinical efficacy of hyperbaric oxygen for the prevention/management of wound complications in this previously irradiated population. The eligibility profile welcomes the involvement of patients in need of laryngectomies for newly diagnosed cancers and for failed chemoradiation. Patients are afforded the opportunity to be cared for by some of the most distinguished head \& neck surgeons and hyperbaric medicine physicians at the University of Pennsylvania in Philadelphia, the oldest teaching medical facility in the country, as well as the Philadelphia Veterans Affairs Medical Center. In addition, participants will be contributing to a body of research uncovering new methods for the assessment of tissue/tumor oxygenation, modeling to promote early wound complication identification, and confirming the role of hyperbaric oxygen therapy in the care and prevention of these problem wounds.

Conditions

Laryngeal Cancer

Keywords

Laryngeal Cancer; Laryngectomy; Tissue Oxygenation; Irradiated Tissue; Hyperbaric Oxygen; Angiogenesis; EF5

Interventions

Hyperbaric Oxygen PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Ara A. Chalian, MD

  Clinical Faculty, Dept. ORLHNS, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Stephen R. Thom, MD PhD

  Chief of Section, Dept. of Hyperbaric Medicine, University of Pennsylvania

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 15, 2001
• First Posted: November 16, 2001
• Study Start: September 1, 2000
• Study Completion: August 1, 2005
• Last Updated: August 18, 2006

Record last verified: 2006-08

Locations

US (1)