Condition category
Cancer
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
18/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes