Hyperbaric Oxygen - a New Treatment Modality in Patients... | NCT01606644

Studies
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue

NCT01606644

Sponsor

Lone Forner

Status

Unknown status

Last Update Posted

May 28, 2012Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Late Effect of Radiation

Interventions

Hyperbaric oxygen

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2014Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

May 6, 2010

First Submission Date that Met QC Criteria

May 25, 2012

First Posted Date

May 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2012

Last Update Posted Date

May 28, 2012Estimated

Name	Class
Danish Cancer Society	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HBO	Experimental	30 90-minute hyperbaric oxygen sessions at 2.4 atm.	Procedure: Hyperbaric oxygen
No HBO	No Intervention	No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric oxygen	Procedure	Inhalation of 100% oxygen for 90 minutes	HBO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivation rate		6 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life		6 months
Xerostomia	Xerostomia questionnaire	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Head and neck cancer with planned radiation therapy
Age > 18 years

Exclusion Criteria:

Surgical treatment of head and neck cancer
Salivary gland disease
Severe claustrophobia
Pregnancy or lactation (fertile women must use safe contraceptives)
Uncontrolled hypertension (> 220/110)
Epilepsy
Lack of ability to equalize inner ear pressure
Pneumothorax
Thoracic surgery within one month before HBO treatment
Abuse of alcohol, drugs or narcotics
Exposed titanium surfaces or defect titanium in the oral cavity
Previous HBO treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lone Forner, DDS, PhD	Contact	+45 3545 8211		lone.forner@rh.regionh.dk

Overall Officials

Name	Affiliation	Role
Lone Forner, DDS, PhD	Copenhagen University Hospital at Herlev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital	Recruiting	Copenhagen		DK-2100	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

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Browse Branches

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