N/A
N=116
A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis
Oral Mucositis
Bottom Line
View on ClinicalTrials.gov: NCT01684566 ↗Enrolled (actual)
116
Serious AEs
4.6%
Results posted
Mar 2016
Primary outcome: Primary: WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population — 0.63; 0.56 score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- episil(R) (Device); Oral hygiene procedures (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Camurus AB
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population |
0.63; 0.56 | — |
| PRIMARY WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population |
0.39; 0.56 | — |
| SECONDARY Occurrence of Oral Mucositis |
44; 40 | — |
| SECONDARY Duration of Oral Mucositis, Intention to Treat Population |
9.5; 10.7 | — |
| SECONDARY Oral Mucositis Daily Questionnaire (OMDQ) |
2.59; 2.64 | — |
| SECONDARY Oral Mucositis Assessment Scale (OMAS) |
0; 0; 0.3; 0.5 | — |
| SECONDARY Hospital Stay, Days |
23.7; 24.5 | — |
| SECONDARY Occurence of Oral Mucositis, Per Protocol Population |
28; 37 | — |
| SECONDARY Duration of Oral Mucositis, Per Protocol Population |
7.4; 10.1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Is at least 18 years of age.
- Has a confirmed diagnosis for which he/she is scheduled for hematopoietic stem cell transplantation (HSCT) of either type of transplant (autologous or allogeneic).
- Is due to undergo treatment with myeloablative conditioning (radiation-based or non radiation based) before HSCT.
Exclusion Criteria
- Will undergo reduced intensity conditioning before HSCT.
- Has got known allergy to any ingredient in the study product or to peanuts, peppermint oil, or soya.
- Is pregnant or breast feeding.
- 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.
- 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.
- Is undergoing treatment with parenteral opioids at enrolment.
- Uses treatments that promote mucosal healing (eg, palifermin).
- Uses electrolyte mouthwashes (eg, Caphosol®) or other topical oral treatments (eg, Tantum Verde® (benzydamine), Gelclair®, Fungicidin (nystatin)).
Data sourced from ClinicalTrials.gov (NCT01684566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.