NCT00682747

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2008

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

May 16, 2008

Last Update Submit

October 26, 2016

Conditions

Radiation-induced Xerostomia

Keywords

xerostomiahyperbaric oxygenationradiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • 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

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

    baseline compared with measures on day 28, 56 and 146

Study Arms (2)

HBO

EXPERIMENTAL

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)

Drug: Hyperbaric oxygen

non HBO

NO INTERVENTION

Interventions

Hyperbaric oxygenDRUG

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

HBO

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy

Halle, 06120, Germany

Location

Druckkammerzentrum Traunstein

Traunstein, 83278, Germany

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Thomas Kuhnt, MD

    University Hospital Rostock, Clinic for Radiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 22, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

DE(2)