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

NCT01684566 | Completed Results

• 1 other identifier: HS-10-396
• Study Type: interventional
• Target: 116
• Locations: 4 countries
• Sites: 12

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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (2)

• WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population

  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

  28 days

• WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population

  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

  28 days

Secondary Outcomes (7)

• Occurrence of Oral Mucositis

  28 days

• Duration of Oral Mucositis, Intention to Treat Population

  28 days

• Oral Mucositis Daily Questionnaire (OMDQ)

  28 days

• Oral Mucositis Assessment Scale (OMAS)

  28 days

• Hospital Stay, Days

  28 days

Study Arms (2)

Standard-Of-Care + episil(R)

EXPERIMENTAL

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

Device: episil(R); Other: Oral hygiene procedures

Standard-Of-Care

OTHER

Oral hygiene procedures

Other: Oral hygiene procedures

Interventions

episil(R) DEVICE

episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.

Standard-Of-Care + episil(R)

Oral hygiene procedures OTHER

Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)

Standard-Of-Care; Standard-Of-Care + episil(R)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)).

Sponsors & Collaborators

• Camurus AB: lead

Study Sites (12)

Med Klinik und Poliklinik I Universitatsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Abteilung fur Hamatologie und Onkologie Universitatsmedizin an der Georg-August-Universitat

Göttingen, 37099, Germany

Location

Rambam Health Care Campus

Haifa, 31096, Israel

Location

Hadassah Medical Centre

Jerusalem, 91240, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

The Tel-Aviv Sourasky Medical Centre

Tel Aviv, 64239, Israel

Location

Military Institute of Medicine Internal diseases and Haemtalogy Clinic

Warsaw, 01141, Poland

Location

Institute of Haematology and Transfusion Medicine

Warsaw, 02776, Poland

Location

Oncology Center Institute named Maria Sklodowska-Curie Lymph System Cancer Clinic

Warsaw, 02781, Poland

Location

Karin Garming-Legert

Stockholm, Huddinge, 141 04, Sweden

Location

Lund University Hospital

Lund, 22185, Sweden

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Håkan Olsson DDS, PhD
• Organization: Camurus AB

Hakan.Olsson@camurus.com

+46 46 2863852

Study Officials

• Karin Garming-Legert, DDS, PhD.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: February 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); IL (4); DE (2); SE (3)