A Preliminary RCT using Standard Therapy Vs Mugard v1

• Research type

  Research Study

• Full title

  A Preliminary Randomised Controlled Trial using Standard Therapy Vs Mugard

• IRAS ID

  42766

• Contact name

  Claire Barber

• Eudract number

  2010-019953-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Oral Mucositis or severe intraoral ulceration is a serious yet customary phenomenon of aggressive chemotherapy and radiotherapy that often triggers a grave sequence of events such as pain, difficulty in swallowing (dysphagia) and malnutrition for the patient. To date no gold standard topical remedy has been identified that can effectively lessen the magnitude of this event and as such, oral Mucositis continues as a functionally destructive complication leading to the need for increased supportive care measures. Few existing studies have explored the effects of Mugard and its barrier forming properties in relieving the symptoms of such oral sequelae, although previous preliminary data has shown promising expectations (Baud et al 2006). The following study has been designed to take these preliminary findings one step further, with the submission of a randomized, controlled trial. Forty patients scheduled to undergo any of the following treatment regimens will be randomized into two groups: ?½ Autologous stem cell transplantation (ASCT) ?½ Chemotherapy or high dose methotrexate for Acute Myeloid Leukaemia (AML) or Acute Lymphoblastic Leukaemia (ALL) ?½ Radiotherapy ﷊❲覢떩 chemotherapy for cancers of the head and neck and where fields include at least 50% of the oral cavity The control group will receive current local Standard Therapy (ST) whilst the treatment group receives Mugard. The main outcomes will be the difference between Oral Mucositis rating scores, time of onset and duration of ulcerative lesions. RESEARCH QUESTION Does the use of Mugard in the management of patients with chemotherapy and/or radiotherapy induced oral Mucositis, offer significant advantage in reducing the time of onset, duration or severity of intraoral lesions? Reference Baud CM, Colon LE, Gerberich J, Nowotnik DP, Howell SB (2006) Protection from Radiation Induced Oral Mucositis by MuGard Oral Rinse A Clinical Study and in silico Analysis. Poster at The 18th International Symposium of the Multinational Association of Supportive Care in Cancer in Toronto, June 2224, 2006.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/93

• Date of REC Opinion

  31 Aug 2010

• REC opinion

  Further Information Favourable Opinion