Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134628
Status:
TERMINATED
Last Update Posted:
2016-01-12
First Post:
2005-08-23
Brief Title:
Study to Determine if Hyperbaric Oxygen Therapy is Helpful for Treating Radiation Tissue Injuries
Sponsor:
National Baromedical Services
Organization:
National Baromedical Services
Study Overview
Official Title:
Hyperbaric Oxygen Radiation Tissue Injury Study - Project HORTIS
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Discontinued cystitis study due to poor recruitment To continue the trial under these circumstances is considered non-viable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The principle objective of this research is to more precisely determine the degree of benefit that hyperbaric oxygen therapy affords in the treatment of late radiation tissue injury
The study has eight components Seven involve the evaluation of established radionecrosis at varying anatomic sites mandible larynx skin bladder rectum colon and gyn The eighth will investigate the potential of hyperbaric oxygen HBO therapy to prophylax against late radiation tissue injury
One of the arms HORTIS IV - Proctitis has been closed to further patient recruitment This decision was based on an interim statistical analysis which generated sufficient evidence to support closing down this arm of HORTIS
The study has eight components Seven involve the evaluation of established radionecrosis at varying anatomic sites mandible larynx skin bladder rectum colon and gyn The eighth will investigate the potential of hyperbaric oxygen HBO therapy to prophylax against late radiation tissue injury
One of the arms HORTIS IV - Proctitis has been closed to further patient recruitment This decision was based on an interim statistical analysis which generated sufficient evidence to support closing down this arm of HORTIS
Detailed Description:
Radiation therapy is a key component of the control and eradication of malignant disease Adequate tumoricidal doses may however result in damage to surrounding healthy tissue Therapeutic radiation injuries to non-target tissues can be divided into acute sub-acute and delayed complications Acute injuries are considered a direct cellular toxicity self-limiting and in most cases successfully managed symptomatically Sub-acute injuries are typically identifiable in only a few organ systems eg radiation pneumonitis These too are generally limited but occasionally evolve to late complications Late changes occur several months to many years after completing radiotherapy
The etiology of radiations late effects to normal tissue LENT varies somewhat between organ systems Its hallmark however is one of culminating in an obliterative endarteritis and local hypoxia
The incidence of LENT is related to both total radiation exposure and the length of time a patient is out from completing radiotherapy The higher the dose the longer the interval from exposure the greater the risk In many cases resulting radionecrotic lesions seriously impair form and function and require extensive surgical correction or repair Such surgery is fraught with complications hence the inclusion of a prophylactic hyperbaric oxygen arm A disturbing degree of mortality further complicates the development of LENT
Hyperbaric oxygen has been utilized in the treatment of radiation tissue injury for several decades Most of the supportive basic science and clinical evidence stems from the management of mandibular osteoradionecrosis More recently the use of hyperbaric oxygen has been extended to other anatomic sites This expanded use is based in large part on a presumed common underlying pathophysiology of LENT regardless of its anatomic location Supportive clinical evidence for these other sites is limited however and in need of a greater degree of scientific scrutiny
The etiology of radiations late effects to normal tissue LENT varies somewhat between organ systems Its hallmark however is one of culminating in an obliterative endarteritis and local hypoxia
The incidence of LENT is related to both total radiation exposure and the length of time a patient is out from completing radiotherapy The higher the dose the longer the interval from exposure the greater the risk In many cases resulting radionecrotic lesions seriously impair form and function and require extensive surgical correction or repair Such surgery is fraught with complications hence the inclusion of a prophylactic hyperbaric oxygen arm A disturbing degree of mortality further complicates the development of LENT
Hyperbaric oxygen has been utilized in the treatment of radiation tissue injury for several decades Most of the supportive basic science and clinical evidence stems from the management of mandibular osteoradionecrosis More recently the use of hyperbaric oxygen has been extended to other anatomic sites This expanded use is based in large part on a presumed common underlying pathophysiology of LENT regardless of its anatomic location Supportive clinical evidence for these other sites is limited however and in need of a greater degree of scientific scrutiny
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN85456814 | None | None | None |