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

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Device: episil(R); Other: Oral hygiene procedures

• Registration Number: NCT01684566
• Lead Sponsor: Camurus AB

Brief 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.

Detailed Description

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.

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Study Timeline

• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Study Start: 2013-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-11
• Results First Submitted: 2015-11-12
• Results First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Results First Posted: 2016-03-14
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

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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)).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-Of-Care + episil(R)	episil(R)	Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
Standard-Of-Care + episil(R)	Oral hygiene procedures	Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed
Standard-Of-Care	Oral hygiene procedures	Oral hygiene procedures

Primary Outcome Measures

Name	Time	Method
WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population	28 days	Summary of WHO (World Health Organisation) Oral Toxicity Scores Area under the curve (AUC) over the 28-Day Period ITT Populations.; A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible
WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population	28 days	Summary of WHO (World Health Organisation) Oral Toxicity Scores AUC Over the 28-Day Period Per protocol population.; A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible

Secondary Outcome Measures

Name	Time	Method
Occurrence of Oral Mucositis	28 days	Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organization) oral toxicity scale grade 0-4.; A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible
Duration of Oral Mucositis, Intention to Treat Population	28 days	Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis was graded according to WHO 5 Point grading scale on a daily basis.; Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible
Oral Mucositis Daily Questionnaire (OMDQ)	28 days	OMDQ (Oral Mucositis Daily Questionnaire) scale was used to measure Overall Mouth and Throat Soreness This was scored from 0=no soreness to 10=worst possible soreness.
Oral Mucositis Assessment Scale (OMAS)	28 days	Summary of Oral Mucositis Assessment Scale (OMAS) Ulceration and Erythema Scores Extent of ulceration (grade 0-3) and severity of erythema (grade 0-2) according to the OMAS (Oral Mucositis Assessment Scale) assessed by a dental practitioner twice-weekly over the 28-day study period.; The extent of ulceration was rated as follows: 0 no lesion; 1. 1 cm2; 2. 1-3 cm2; 3. \>3 cm2; The severity of erythema was assessed as follows: 0 none; 1. not severe; 2. severe
Hospital Stay, Days	28 days	Duration of hospital stay (time from admission to discharge)
Occurence of Oral Mucositis, Per Protocol Population	28 days	Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organisation) oral toxicity scale grade 0-4; A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible
Duration of Oral Mucositis, Per Protocol Population	28 days	Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis is graded according to the 5-point oral mucositis WHO scale Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible

Trial Locations

Locations (12)

Karin Garming-Legert; 🇸🇪 Stockholm, Huddinge, Sweden

Lund University Hospital; 🇸🇪 Lund, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Hadassah Medical Centre; 🇮🇱 Jerusalem, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Institute of Haematology and Transfusion Medicine; 🇵🇱 Warszawa, Poland

Abteilung fur Hamatologie und Onkologie Universitatsmedizin an der Georg-August-Universitat; 🇩🇪 Gottingen, Germany

Med Klinik und Poliklinik I Universitatsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Military Institute of Medicine Internal diseases and Haemtalogy Clinic; 🇵🇱 Warszawa, Poland

The Tel-Aviv Sourasky Medical Centre; 🇮🇱 Tel Aviv, Israel

Oncology Center Institute named Maria Sklodowska-Curie Lymph System Cancer Clinic; 🇵🇱 Warszawa, Poland