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Clinical Trials/EUCTR2010-019953-16-GB
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.

Registry
who.int
Start Date
June 17, 2010
End Date
September 16, 2013
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Royal Devon & Exeter Foundation Trust

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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