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

Radiation-induced Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00682747
• Other study ID #: KKSH-037
• Status: Terminated
• Phase: Phase 2
• First received: May 16, 2008
• Last updated: October 26, 2016
• Start date: May 2008
• Est. completion date: March 2011

Study information

• Verified date: October 2016
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiation-induced Xerostomia
• Xerostomia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy	Halle
Germany	Druckkammerzentrum Traunstein	Traunstein

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Kuhnt	Verband Deutscher Druckkammerzentren

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of overall salivation (millilitre per minute over 5 minutes measured at rest and after provocation) in percentages		baseline compared with measures on day 28, 56 and 146	No
Secondary	Number of Adverse Events in all patients as a Measure of Safety and Tolerability		baseline until 4 weeks after end of study treatment	Yes
Secondary	Xerostomia scores assessed by investigator according to Eisbruch et.al.		baseline compared with measures on day 28, 56 and 146	No
Secondary	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	No
Secondary	quality of life measures (EORTC QLQ-H&N 35)		baseline compared with measures on day 28, 56 and 146	No