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Randomised double-blind placebo controlled study to determine whether the use of selective digestive decontamination pastilles reduces radiation mucositis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67519330
Enrollment
Unknown
Registered
2001-07-01
Start date
1999-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck Cancer Head and neck

Interventions

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 reactio

Sponsors

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration—

Secondary

MeasureTime frame
Not provided at time of registration—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026