E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028130 |
E.1.2 | Term | Mucositis oral |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028128 |
E.1.2 | Term | Mucositis management |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the feasibility of conducting a trial to explore the effectiveness of d-α-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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of the feasibility of conducting a large-scale multi-site RCT of d-α-tocopherol in the management of oral mucositis in a population of patients undergoing conditioning for stem cell transplantation. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Feasibility of conducting a larger study. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is defined as last visit of the last patient undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |