Randomised double-blind placebo controlled study to determine whether the use of selective digestive decontamination pastilles reduces radiation mucositis
| ISRCTN | ISRCTN67519330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67519330 |
| Protocol serial number | HN9 |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | Not available |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 02/02/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Head and neck |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/1996 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
