Prevention of radiotherapy side-effects by early hyperbaric oxygen administration
| ISRCTN | ISRCTN25123615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25123615 |
| Secondary identifying numbers | MEC 2005-318; NTR617 |
- Submission date
- 04/04/2006
- Registration date
- 04/04/2006
- Last edited
- 18/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Prof P.C. Levendag
Scientific
Scientific
Erasmus Medical Centre
Department of Radiotherapy
Groenehilledijk 301
Rotterdam
3075 EA
Netherlands
| p.levendag@erasmusmc.nl |
Study information
| Study design | Randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 1. Xerostomia 2. Mucositis 3. Trismus |
| Secondary outcome measures | 1. Tumour control 2. Quality of life |
| Overall study start date | 06/02/2006 |
| Completion date | 06/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3075 EA
Netherlands
3075 EA
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
