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

NCT ID: NCT00682747

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Radiation-induced Xerostomia

Keywords

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xerostomia hyperbaric oxygenation radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HBO

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)

Group Type EXPERIMENTAL

Hyperbaric oxygen

Intervention Type DRUG

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

non HBO

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyperbaric oxygen

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Verband Deutscher Druckkammerzentren

UNKNOWN

Sponsor Role collaborator

Thomas Kuhnt

OTHER

Sponsor Role lead

Responsible Party

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Thomas Kuhnt

Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas Kuhnt, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Rostock, Clinic for Radiotherapy

Locations

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Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy

Halle, , Germany

Site Status

Druckkammerzentrum Traunstein

Traunstein, , Germany

Site Status

Countries

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Germany

Other Identifiers

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KKSH-037

Identifier Type: -

Identifier Source: org_study_id