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 oral MedDRA version: 9.1 Level: PT Classification code 100
Conditions
Interventions
Product Name: D-Alpha-Tocopherol
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo:
Sponsors
Christie Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of conducting a trial to explore the effectiveness of d-a-tocopherol in the management of oral mucositis compared to a soya bean oil placebo, over and above standard care, in a sample of patients undergoing conditioning for bone marrow transplantation.; Secondary Objective: 1) To compare the duration of ulcerative mucositis in the intervention group to those of the control group in a sample of patients undergoing conditioning for bone marrow transplantation. 2) To compare the highest mean mucositis scores generated by the Daily Index of Mucositis (DIM) tool between the two groups. 3) To compare mean nutritional screening scores between the intervention and control groups. 4) To compare patients’ reports of oral pain between the intervention and control groups. 5) To compare the number of days that intravenous (IV) narcotic therapy is required for oral mucositis pain between the intervention and control groups. 6) To compare the number of episodes of diarrhoea between the two groups. 7) To collect information about the levels of vitamin supplementation used by patients undergoing bone marrow transplantation. ;Primary end point(s): Assessment of the feasibility of conducting a large-scale multi-site RCT of d-a-tocopherol in the management of oral mucositis in a population of patients undergoing conditioning for stem cell transplantation. | — |
Countries
United Kingdom
Outcome results
None listed