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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01606644

Enrollment

Registered

2012-05-28

Start date

2010-05-31

Completion date

2014-04-30

Last updated

2012-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late Effect of Radiation

Keywords

radiation sequelae, hyperbaric oxygen

Brief summary

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

Interventions

PROCEDUREHyperbaric oxygen

Inhalation of 100% oxygen for 90 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Salivation rate	6 months

Secondary

Measure	Time frame	Description
Quality of life	6 months	—
Xerostomia	6 months	Xerostomia questionnaire

Countries

Denmark

Contacts

Primary ContactLone Forner, DDS, PhD

lone.forner@rh.regionh.dk+45 3545 8211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026