Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Camurus AB
ClinicalTrials.gov Identifier:
NCT01684566
First received: September 11, 2012
Last updated: February 17, 2016
Last verified: November 2015
  Purpose
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.

Condition Intervention
Oral Mucositis
Device: episil(R)
Other: Oral hygiene procedures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Camurus AB:

Primary Outcome Measures:
  • WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Duration of hospital stay (time from admission to discharge)

  • Occurence of Oral Mucositis, Per Protocol Population [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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


Enrollment: 116
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard-Of-Care + 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
Device: episil(R)
episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
Other: Oral hygiene procedures
Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)
Standard-Of-Care
Oral hygiene procedures
Other: Oral hygiene procedures
Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684566

Locations
Germany
Med Klinik und Poliklinik I Universitatsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Abteilung fur Hamatologie und Onkologie Universitatsmedizin an der Georg-August-Universitat
Gottingen, Germany, 37099
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Hadassah Medical Centre
Jerusalem, Israel, 91240
Rabin Medical Center
Petah Tikva, Israel, 49100
The Tel-Aviv Sourasky Medical Centre
Tel Aviv, Israel, 64239
Poland
Military Institute of Medicine Internal diseases and Haemtalogy Clinic
Warszawa, Poland, 01141
Institute of Haematology and Transfusion Medicine
Warszawa, Poland, 02776
Oncology Center Institute named Maria Sklodowska-Curie Lymph System Cancer Clinic
Warszawa, Poland, 02781
Sweden
Karin Garming-Legert
Stockholm, Huddinge, Sweden, 141 04
Lund University Hospital
Lund, Sweden, 22185
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Camurus AB
Investigators
Principal Investigator: Karin Garming-Legert, DDS, PhD. Karolinska Institutet, Stockholm, Sweden
  More Information

Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT01684566     History of Changes
Other Study ID Numbers: HS-10-396 
Study First Received: September 11, 2012
Results First Received: November 12, 2015
Last Updated: February 17, 2016
Health Authority: Israel: Ministry of Health
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on December 02, 2016