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van CCT (UK)


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


- candidate number2000
- NTR NumberNTR617
- ISRCTNISRCTN25123615
- Date ISRCTN created4-apr-2006
- date ISRCTN requested24-mrt-2006
- Date Registered NTR3-mrt-2006
- Secondary IDsMEC 2005-318 
- Public TitlePrevention of radiotherapy side-effects by early hyperbaric oxygen administration.
- Scientific TitlePrevention of radiotherapy side-effects by early hyperbaric oxygen administration.
- ACRONYMN/A
- hypothesisPrevention of radiotherapy side-effects by early hyperbaric oxygen administration.
- Healt Condition(s) or Problem(s) studiedOropharyngeal cancer, Nasopharyngeal cancer
- Inclusion criteria1. Curative intent; 2. Presence of oropharynx en nasopharynx tumours.
- Exclusion criteriaPalliative treatment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 6-feb-2006
- planned closingdate6-feb-2009
- Target number of participants180
- InterventionsRandomisation of Hyperbaric Oxygen (one group with and one group without). Treatment consists of 30 sessions of 2 hours a day.
- Primary outcome1. Xerostomia; 2. Mucositis; 3. Trismus.
- Secondary outcome1. Tumor control; 2. Quality of Life.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.C. Levendag
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.C. Levendag
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryAfter regular treatment of oropharyngeal and nasopharyngeal tumours. Patients are randomized to treatment with or without Hyperbaric Oxygen.
- Main changes (audit trail)
- RECORD3-mrt-2006 - 12-apr-2006


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