A Preliminary Randomised Controlled Trial using Standard Therapy Vs Mugard - A Preliminary RCT using Standard Therapy Vs Mugard v1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019953-16-GB

Enrollment

Registered

2010-06-17

Start date

2010-08-31

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Chemotherapy and radiotherapy induced oral mucositis

Interventions

Trade Name: Mugard Product Name: MUGARD Product Code: n/a Pharmaceutical Form: Mouth wash Trade Name: Benzydamine Hydrochloride

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients • over the age of 18 years old • With a diagnosis of head and neck cancer who are to receive at least 50Gy of radiotherapy, with or without concomitant / neoadjuvant chemotherapy and where fields include at least 50% of the oral cavity. • With a diagnosis of Acute Myeloid Leukaemia (AML) or Acute Lymphoblastic Leukaemia (ALL) who are due to receive intensive chemotherapy • Patients receiving high dose methotrexate • Undergoing autologous stem cell transplantation • Written informed consent as a positive 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: Patients who • Are unable to give written informed consent • Are unable to comprehend or record the self-reporting questionnaires, which will be used to assess symptoms. • Are allergic to any of the constituents of Mugard or standard therapy. • Are expected to move to another institution before completion of this study. • Show signs of existing oral mucositis before commencement of treatment • Are under the age of 18 years

Design outcomes

Primary

Measure	Time frame
Main Objective: Does the use of Mugard in the management of patients with chemotherapy and/or radiotherapy-induced oral mucositis (severe intraoral ulceration), offer significant advantage in reducing the time of onset, duration or severity of intraoral lesions?; Secondary Objective: Secondary Response Criteria • Tolerability • Pain • Ability to eat and drink • Recruitment rate • Concordance rate • Attrition / Follow up • Acceptability of trial events • Acceptable data collection methods • Acceptable data capturing tools • Acceptable delivery of intervention • Refining interventions • Assessment of resources needed for large scale trial • Obtaining estimate of SD of outcome measures • Obtain estimate of ICC of outcome measures ;Primary end point(s): Time of onset, duration and severity of intraoral lesions	—

Measure

Time frame

Main Objective: Does the use of Mugard in the management of patients with chemotherapy and/or radiotherapy-induced oral mucositis (severe intraoral ulceration), offer significant advantage in reducing the time of onset, duration or severity of intraoral lesions?; Secondary Objective: Secondary Response Criteria • Tolerability • Pain • Ability to eat and drink • Recruitment rate • Concordance rate • Attrition / Follow up • Acceptability of trial events • Acceptable data collection methods • Acceptable data capturing tools • Acceptable delivery of intervention • Refining interventions • Assessment of resources needed for large scale trial • Obtaining estimate of SD of outcome measures • Obtain estimate of ICC of outcome measures ;Primary end point(s): Time of onset, duration and severity of intraoral lesions

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Countries

United Kingdom

Outcome results

None listed

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