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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
episil(R)
Oral hygiene procedures
Sponsored by
Camurus AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)).

Sites / Locations

  • Med Klinik und Poliklinik I Universitatsklinikum Carl Gustav Carus
  • Abteilung fur Hamatologie und Onkologie Universitatsmedizin an der Georg-August-Universitat
  • Rambam Health Care Campus
  • Hadassah Medical Centre
  • Rabin Medical Center
  • The Tel-Aviv Sourasky Medical Centre
  • Military Institute of Medicine Internal diseases and Haemtalogy Clinic
  • Institute of Haematology and Transfusion Medicine
  • Oncology Center Institute named Maria Sklodowska-Curie Lymph System Cancer Clinic
  • Karin Garming-Legert
  • Lund University Hospital
  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Standard-Of-Care + episil(R)

Standard-Of-Care

Arm Description

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

Oral hygiene procedures

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Occurrence of Oral Mucositis
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
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)
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)
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 cm2 1-3 cm2 >3 cm2 The severity of erythema was assessed as follows: 0 none not severe severe
Hospital Stay, Days
Duration of hospital stay (time from admission to discharge)
Occurence of Oral Mucositis, Per Protocol Population
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
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

Full Information

First Posted
September 11, 2012
Last Updated
February 17, 2016
Sponsor
Camurus AB
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1. Study Identification

Unique Protocol Identification Number
NCT01684566
Brief Title
A Comparative Investigation of Standard Of Care (SOC) and Episil® in Combination Versus SOC Alone on Oral Mucositis
Acronym
episil(R)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camurus AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard-Of-Care + episil(R)
Arm Type
Experimental
Arm Description
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
Arm Title
Standard-Of-Care
Arm Type
Other
Arm Description
Oral hygiene procedures
Intervention Type
Device
Intervention Name(s)
episil(R)
Intervention Description
episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Intervention Type
Other
Intervention Name(s)
Oral hygiene procedures
Intervention Description
Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)
Primary Outcome Measure Information:
Title
WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population
Description
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
Time Frame
28 days
Title
WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Occurrence of Oral Mucositis
Description
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
Time Frame
28 days
Title
Duration of Oral Mucositis, Intention to Treat Population
Description
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
Time Frame
28 days
Title
Oral Mucositis Daily Questionnaire (OMDQ)
Description
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.
Time Frame
28 days
Title
Oral Mucositis Assessment Scale (OMAS)
Description
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 cm2 1-3 cm2 >3 cm2 The severity of erythema was assessed as follows: 0 none not severe severe
Time Frame
28 days
Title
Hospital Stay, Days
Description
Duration of hospital stay (time from admission to discharge)
Time Frame
28 days
Title
Occurence of Oral Mucositis, Per Protocol Population
Description
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
Time Frame
28 days
Title
Duration of Oral Mucositis, Per Protocol Population
Description
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Garming-Legert, DDS, PhD.
Organizational Affiliation
Karolinska Institutet, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Med Klinik und Poliklinik I Universitatsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Abteilung fur Hamatologie und Onkologie Universitatsmedizin an der Georg-August-Universitat
City
Gottingen
ZIP/Postal Code
37099
Country
Germany
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Centre
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Tel-Aviv Sourasky Medical Centre
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Military Institute of Medicine Internal diseases and Haemtalogy Clinic
City
Warszawa
ZIP/Postal Code
01141
Country
Poland
Facility Name
Institute of Haematology and Transfusion Medicine
City
Warszawa
ZIP/Postal Code
02776
Country
Poland
Facility Name
Oncology Center Institute named Maria Sklodowska-Curie Lymph System Cancer Clinic
City
Warszawa
ZIP/Postal Code
02781
Country
Poland
Facility Name
Karin Garming-Legert
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
141 04
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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