A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis

A Multicenter, Open-label, Parallel Group Investigation to Compare the Performance of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis in Patients Receiving Conditioning Treatment for Hematopoietic Stem Cell Transplantation

To compare the performance of standard of care (SOC) + episil® versus SOC alone on oral mucositis in patients receiving conditioning treatment for hematopoietic stem cell transplantation (HSCT). The primary variable will be the area under the curve (AUC) of oral mucositis scores defined by the World Health Organisation (WHO) oral toxicity scale assessed daily by the investigator over the 28-day study period.

This was multicentre, open-label, randomised parallel-group study. Patients were randomised to one of two parallel treatment groups: episil® in combination with SOC or SOC alone.

The study was originally planned to be conducted in several sites in the following countries: Denmark, Israel, Poland, and Sweden. Following a country-specific Amendment on 20-Feb-2013 and a German Ethical Committee (EC) approval in 07-May-2013, Germany was added to the list of countries where the study would be conducted. No study sites were initiated in Denmark.

The study design was aimed to facilitate direct comparison of the performance of SOC + episil® versus SOC alone. The study was conducted in an open-label manner that is common in trials involving cancer patients, as this takes into the account the ethical issues involved in this indication and patient population. To reduce the likelihood of bias, assignment to study treatment was randomised.

SOC as control group is appropriate and widely used, especially in trials involving cancer patients. In this particular study, basic oral hygiene consisting of brushing, flossing, rinsing and moisturising was taken as the SOC used as control group.

.

Inclusion Criteria:

1. Is at least 18 years of age.
2. Has a confirmed diagnosis for which he/she is scheduled for hematopoietic stem cell transplantation (HSCT) of either type of transplant (autologous or allogeneic).
3. Is due to undergo treatment with myeloablative conditioning (radiation-based or non radiation based) before HSCT.

Exclusion Criteria:

1. Will undergo reduced intensity conditioning before HSCT.
2. Has got known allergy to any ingredient in the study product or to peanuts, peppermint oil, or soya.
3. Is pregnant or breast feeding.
4. Has any other concurrent medical condition that, in the opinion of the investigator, would increase the risk to the patient, compromise evaluation of the investigational device, or interfere with the conduct of the study.
5. Has an unstable condition (eg, a psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the study requirements.
6. Is undergoing treatment with parenteral opioids at enrolment.
7. Uses treatments that promote mucosal healing (eg, palifermin).
8. Uses electrolyte mouthwashes (eg, Caphosol®) or other topical oral treatments (eg, Tantum Verde® (benzydamine), Gelclair®, Fungicidin (nystatin)).