A phase II study of bethanechol chloride to treat pseudomembranous candidosis in cancer patients with salivary gland dysfunction. - BOC study

Phase 1

• Conditions: Oral candidosis (pseudomembranous subtype)

• Registration Number: EUCTR2006-004282-34-GB
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Diagnosis of cancer.
2. Age > 18yr.
3. ECOG performance status 0-3.
4. Prognosis > 4 weeks.
5. Presence of salivary gland dysfunction.
6. Presence of pseudomembranous candidosis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of non-malignant disease.
2. Age < 18yr.
3. ECOG performance status 4.
4. Prognosis < 4 weeks.
5. Absence of salivary gland dysfunction.
6. Radiation-induced salivary gland dysfunction.
7. Current treatment with antifungal medication.
8. Contraindications to use of bethanechol chloride.
9. Significant cognitive impariment.
10. Significant physical impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified