| Source of record | UK Trials |
| ISRCTN | ISRCTN67519330 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | HN9 |
| Public title | Randomised double-blind placebo controlled study to determine whether the use of selective digestive decontamination pastilles reduces radiation mucositis |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Head and neck |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients with head and neck cancer receiving potentially curative doses of radiotherapy
2. Eligible patients may have squamous carcinoma, adenocarcinoma or salivary tumours arising in the oral cavity, nas -oro, or hypopharynx, larynx and paranasal sinuses
3. Stages T1-T4
4. No allergy to Polymyxin E, Tobramycin or Amphotericin B
5. No pre-existing oral or oropharyngeal infection |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients randomised to one of two treatment groups:
1. Group A: Active SSD pastille (Polymyxin E 2 mg, Tobramycin 1.8 mg and Amphotericin B 10 mg). Treatment to start on the day radiotherapy begins, one pastille four times daily until radiation reactions have settled.
2. Group B: Placebo pastille four times daily. Treatment to start on the first day of radiotherapy until radiation reactions have settled. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN67519330 |
| Date last extracted from ISRCTN register | 17/04/2008 |
