Prevention of radiotherapy side-effects by early hyperbaric oxygen administration.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR617
• Date of registration: 03/03/2006
• Primary sponsor: Erasmus Medical Center
• Public title: Prevention of radiotherapy side-effects by early hyperbaric oxygen administration.
• Scientific title: Prevention of radiotherapy side-effects by early hyperbaric oxygen administration. - N/A
• Date of first enrolment: 6/2/2006
• Target sample size: 180
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=617
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: P.C. Levendag

• Name: P.C. Levendag

Key inclusion & exclusion criteria

Inclusion criteria: 1. Curative intent;
2. Presence of oropharynx en nasopharynx tumours.
Exclusion criteria: Palliative treatment.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Oropharyngeal cancer, Nasopharyngeal cancer

Intervention(s)

Randomisation of Hyperbaric Oxygen (one group with and one group without). Treatment consists of 30 sessions of 2 hours a day.

Primary Outcome(s)

1. Xerostomia;
2. Mucositis;
3. Trismus.

Secondary Outcome(s)

1. Tumor control;
2. Quality of Life.

Secondary ID(s)

ISRCTN25123615

MEC 2005-318

Source(s) of Monetary Support

Erasmus Medical Center