Prevention of radiotherapy side-effects by early hyperbaric oxygen administration

ISRCTN	ISRCTN25123615
DOI	https://doi.org/10.1186/ISRCTN25123615
Protocol serial number	MEC 2005-318; NTR617
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Erasmus Medical Centre (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof P.C. Levendag
Scientific

Erasmus Medical Centre
Department of Radiotherapy
Groenehilledijk 301
Rotterdam
3075 EA
Netherlands

Email	p.levendag@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To prevent radiotherapy side-effects with early hyperbaric oxygen administration.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Xerostomia 2. Mucositis 3. Trismus
Key secondary outcome measure(s)	1. Tumour control 2. Quality of life
Completion date	06/02/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	180
Key inclusion criteria	1. Curative intent 2. Presence of oropharynx and nasopharynx tumours
Key exclusion criteria	Palliative treatment
Date of first enrolment	06/02/2006
Date of final enrolment	06/02/2009

Erasmus Medical Centre

Rotterdam
3075 EA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan