Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026975
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-11-15
Brief Title:
Efficacy of Hyperbaric Oxygen Therapy in Laryngectomy Patients
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Clinical Outcomes Modeling for Laryngectomy Surgery Patients and Efficacy of Hyperbaric Oxygen Therapy
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to develop a predictive model for the development of wound complications in patients undergoing laryngectomy surgery for laryngealadjoining structure cancers and to evaluate the clinical efficacy of hyperbaric oxygen for the preventionmanagement 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 tissuetumor 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
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 hypoxiavascularization 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
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 hypoxiavascularization 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None