EUCTR2010-019953-16-GB
Active, not recruiting
Phase 1
A Preliminary Randomised Controlled Trial using Standard Therapy Vs Mugard - A Preliminary RCT using Standard Therapy Vs Mugard v1
Royal Devon & Exeter Foundation Trust0 sites16 target enrollmentJune 17, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chemotherapy and radiotherapy induced oral mucositis
- Sponsor
- Royal Devon & Exeter Foundation Trust
- Enrollment
- 16
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Not specified
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