Randomized Phase II Trial of Hyperbaric Oxygen for the Treatment of Radiation-induced Xerostomia

Thomas Kuhnt2 sites in 1 country13 target enrollmentMay 2008

ConditionsRadiation-induced Xerostomia

InterventionsHyperbaric oxygen

DrugsHyperbaric oxygen

Overview

Phase: Phase 2
Intervention: Hyperbaric oxygen
Conditions: Radiation-induced Xerostomia
Sponsor: Thomas Kuhnt
Enrollment: 13
Locations: 2
Primary Endpoint: change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

March 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Thomas Kuhnt

Responsible Party

Sponsor Investigator

Principal Investigator

Thomas Kuhnt

Dr. med.

Martin-Luther-Universität Halle-Wittenberg

Eligibility Criteria

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

Arms & Interventions

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)

Intervention: Hyperbaric oxygen

Outcomes

Primary Outcomes

change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages

Time Frame: baseline compared with measures on day 28, 56 and 146

Secondary Outcomes

Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale(baseline compared with measures on day 28, 56 and 146)
Number of Adverse Events in all patients as a Measure of Safety and Tolerability(baseline until 4 weeks after end of study treatment)
Xerostomia scores assessed by investigator according to Eisbruch et.al.(baseline compared with measures on day 28, 56 and 146)
quality of life measures (EORTC QLQ-H&N 35)(baseline compared with measures on day 28, 56 and 146)