Back to results

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

Primary Purpose

Radiation-induced Xerostomia

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Hyperbaric oxygen

About this trial

This is an interventional treatment trial for Radiation-induced Xerostomia focused on measuring xerostomia, hyperbaric oxygenation, radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy
Druckkammerzentrum Traunstein

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HBO

non HBO

Arm 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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Adverse Events in all patients as a Measure of Safety and Tolerability

Xerostomia scores assessed by investigator according to Eisbruch et.al.

Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale

quality of life measures (EORTC QLQ-H&N 35)

Full Information

NCT ID

NCT00682747

First Posted

May 16, 2008

Last Updated

October 26, 2016

Sponsor

Thomas Kuhnt

Collaborators

Verband Deutscher Druckkammerzentren

1. Study Identification

Unique Protocol Identification Number

NCT00682747

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Terminated

Why Stopped

poor recruitment

Study Start Date

May 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Kuhnt

Collaborators

Verband Deutscher Druckkammerzentren

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiation-induced Xerostomia

Keywords

xerostomia, hyperbaric oxygenation, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HBO

Arm Type

Experimental

Arm Description

Arm Title

non HBO

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Hyperbaric oxygen

Intervention Description

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Number of Adverse Events in all patients as a Measure of Safety and Tolerability

Time Frame

baseline until 4 weeks after end of study treatment

Title

Xerostomia scores assessed by investigator according to Eisbruch et.al.

Time Frame

baseline compared with measures on day 28, 56 and 146

Title

Improvement of symptoms/discomfort due to xerestomia assessed by the patient on a visual analogue scale

Time Frame

baseline compared with measures on day 28, 56 and 146

Title

quality of life measures (EORTC QLQ-H&N 35)

Time Frame

baseline compared with measures on day 28, 56 and 146

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Kuhnt, MD

Organizational Affiliation

University Hospital Rostock, Clinic for Radiotherapy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

Druckkammerzentrum Traunstein

City

Traunstein

ZIP/Postal Code

83278

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs