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

Phase 1

• Conditions: Chemotherapy and radiotherapy induced oral mucositis

• Registration Number: EUCTR2010-019953-16-GB
• Lead Sponsor: Royal Devon & Exeter Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-17
• Study Completion: 2013-09-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 16

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

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

Study & Design

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