Assessing the Feasibility of a Single Blind Randomised Controlled Trial to Measure the Effectiveness of D-Alpha-Tocopherol in the Management of Oral Mucositis in Patients Undergoing Conditioning for Bone Marrow Transplantation. - D-Alpha-Tocopherol in the Management of Oral Mucositis
- Conditions
- This trial will assess the D-alpha-Tocopherol in the management of Oral Mucositis. Nutritional status will be assessed using the patient generated subjective oral assessment tool to monitor cancer cachexia. Patient's levels of pain will be assessed.MedDRA version: 9.1 Level: LLT Classification code 10028130 Term: Mucositis oralMedDRA version: 9.1 Level: PT Classification code 10028128 Term: Mucositis management
- Registration Number
- EUCTR2007-004749-14-GB
- Lead Sponsor
- Christie Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 66
Both male and female subjects will be recruited to take part in this study. The inclusion criteria are as follows:
•Patient aged 18 years old or over.
•Patient diagnosed with Leukaemia, Lymphoma or Multiple Myeloma
•Patient undergoing conditioning for BMT/ PBPC transplantation
•WHO mucositis score of 0
•Patient not enrolled in other oral mucositis trials
•Patients treated as inpatients
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
The exclusion criterion consists of the opposite of the inclusion criteria listed above and in addition includes:
•Patients who have a religious or dietary exception to gelatin.
•Patients currently prescribed warfarin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method