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

Late Effect of Radiation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01606644
• Other study ID #: HBO Copenhagen study
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2010
• Last updated: May 25, 2012
• Start date: May 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2012
• Source: Rigshospitalet, Denmark
• Contact: Lone Forner, DDS, PhD
• Phone: +45 3545 8211
• Email: lone.forner[@]rh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Late Effect of Radiation

Intervention

Procedure:
• Hyperbaric oxygen
Inhalation of 100% oxygen for 90 minutes

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Lone Forner	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivation rate		6 months	No
Secondary	Quality of life		6 months	No
Secondary	Xerostomia	Xerostomia questionnaire	6 months	No