Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy

Thomas Kuhnt

Status and phase: Terminated; Phase 2

Conditions: Radiation-induced Xerostomia

Treatments: Drug: Hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT00682747

KKSH-037

Details and patient eligibility

About

The purpose of this study is to determine whether hyperbaric oxygen is effective in the treatment of a dry mouth that occured after radiotherapy for head and neck tumours.

Enrollment: 13 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• complaints of xerostomia (visual analogue scale)
• at least 6 months after radiotherapy of the head and neck region including all salivary glands with at least 50 Gy
• objective hyposalivation / xerostomia (at rest < 0,25 ml saliva per minute, stimulated < 0,1 ml saliva per minute)
• patient must have given written informed consent

Exclusion criteria

• prior radiotherapy was an intensity modulated radiotherapy
• prior hyperbaric oxygen therapy after radiotherapy
• conditions which might be an additional risk for the treatment with hyperbaric oxygen such as spontaneous pneumothorax within the last two years, surgery of the eardrum or the middle ear, acute infection of the upper airways, not adequately treated epilepsy, concurrent radio- or chemotherapy, hereditary spherocytosis, psychosis, lung emphysema, asthma, severe COPD, prior surgery of the thorax, pace maker
• myocardial infarction within the last 6 months
• drug therapy which might induce xerostomia
• known intolerance or hypersensitivity to Wrigley's Freident®
• pregnancy or breast-feeding women (for women aged less than 60 years a pregnancy test is mandatory)
• women of childbearing potential with unclear contraception. The following contraceptive methods are recommended: combined oral contraceptives or progesterone-only pill, hormone-dispensing or copper intra-uterine system, hormone patches, long-acting injections, vaginal ring
• treatment with other investigational drugs or participation in another clinical trial within 30 days prior to enrollment
• refusal of cooperation or consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

HBO

Experimental group

Description:

40 treatments with hyperbaric oxygen once per day, five days per week, 2.4 ATA, 100 % oxygen (10-15 minutes compression with air, 90 min of oxygen breathing - two 10 minutes break for breathing air after each 30 minutes of oxygen, 10 minutes decompression with oxygen)

Treatment:

Drug: Hyperbaric oxygen

non HBO

No Intervention group