Contact information
Type
Scientific
Primary contact
Prof P.C. Levendag
ORCID ID
Contact details
Erasmus Medical Centre
Department of Radiotherapy
Groenehilledijk 301
Rotterdam
3075 EA
Netherlands
p.levendag@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MEC 2005-318; NTR617
Study information
Scientific title
Acronym
Study hypothesis
To prevent radiotherapy side-effects with early hyperbaric oxygen administration.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Nasopharyngeal cancer, oropharyngeal cancer
Intervention
Randomisation of hyperbaric oxygen (one group with and one group without). Treatment consists of 30 sessions of 2 hours a day.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Xerostomia
2. Mucositis
3. Trismus
Secondary outcome measures
1. Tumour control
2. Quality of life
Overall trial start date
06/02/2006
Overall trial end date
06/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Curative intent
2. Presence of oropharynx and nasopharynx tumours
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
180
Participant exclusion criteria
Palliative treatment
Recruitment start date
06/02/2006
Recruitment end date
06/02/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3075 EA
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary