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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004282-34-GB

Enrollment

Unknown

Registered

2006-09-29

Start date

2006-10-13

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Oral candidosis (pseudomembranous subtype)

Interventions

Trade Name: Myotonine Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of bethanechol chloride in treating pseudomembranous oral candidosis in patients with salivary gland dysfunction.;Secondary Objective: 1) To assess the tolerability of bethanechol chloride in this scenario. 2) To assess the effect of bethanechol chloride on oral yeast colonisation (yeast species, yeast numbers). 3) To assess the effect of bethanechol chloride on salivary gland dysfunction (xerostomia, salivary flow rates).;Primary end point(s): The primary endpoint is the presence or absence of clinical disease after 14 days of treatment.	—

Measure

Time frame

Main Objective: To assess the efficacy of bethanechol chloride in treating pseudomembranous oral candidosis in patients with salivary gland dysfunction.;Secondary Objective: 1) To assess the tolerability of bethanechol chloride in this scenario. 2) To assess the effect of bethanechol chloride on oral yeast colonisation (yeast species, yeast numbers). 3) To assess the effect of bethanechol chloride on salivary gland dysfunction (xerostomia, salivary flow rates).;Primary end point(s): The primary endpoint is the presence or absence of clinical disease after 14 days of treatment.

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Countries

United Kingdom

Outcome results

None listed

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