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

Phase 2
18 Years
75 Years
Open (Enrolling)
Radiation-Induced Xerostomia

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

baseline compared with measures on day 28, 56 and 146

Safety Issue:


Principal Investigator

Thomas Kuhnt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Martin Luther University Halle-Wittenberg, Clinic for Radiotherapy


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

May 2008

Completion Date:

October 2009

Related Keywords:

  • Radiation-Induced Xerostomia
  • xerostomia
  • hyperbaric oxygenation
  • radiotherapy
  • Xerostomia