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

Lone Forner

Status and phase: Unknown; Phase 3

Conditions: Late Effect of Radiation

Treatments: Procedure: Hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01606644

HBO Copenhagen study

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

HBO

Experimental group

Description:

30 90-minute hyperbaric oxygen sessions at 2.4 atm.

Treatment:

Procedure: Hyperbaric oxygen

No HBO

No Intervention group

Description:

No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program.