Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02816515
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bitop AG

Brief Summary:
This is a 3-week, non-interventional, observational study of patients undergoing chemotherapy (sutent) designed as a three-arm parallel study. In this study, the efficacy of Ectoin containing mouthwash given prophylactically for the prevention of mucositis in patients before radio- and/or chemotherapy; as well as during radio- and/or chemotherapy for patients with mucositis compared to standard treatment should be investigated. The study doesn't intervene with routine treatment strategy.

Condition or disease
Mucositis

Layout table for study information
Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Study Start Date : January 2016
Actual Primary Completion Date : October 24, 2017
Actual Study Completion Date : October 24, 2017

Group/Cohort
Ectoin® mouth wash
The treatment will be started on the first day of radio- and/or chemotherapy, before development of mucositis
Ectoin mouth wash
The treatment will be started after oral mucositis development in patients receiving radio- and/or chemotherapy
Supersaturated electrolyte mouth rinse
The treatment will be started after oral mucositis development in patients receiving radio and/or chemotherapy



Primary Outcome Measures :
  1. Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort [ Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) ]
    A trained clinical member of the team scores the degree of oral mucositis, in accordance to the World Health Organization (WHO) mucositis scale as follow: grade 0, no signs or symptoms; grade 1, oral soreness and erythema; grade 2, oral erythema, ulcers and solid diet tolerated; grade 3, oral ulcers and liquid diet only; grade 4, oral alimentation impossible

  2. Tolerability assessment of Ectoin Mouth Wash by using a subsequent patient questionnaire in the prevention and suppression of the severity of oral mucositis induced by radio- and/or chemotherapy. [ Time Frame: day 21 ]
  3. Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire [ Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) ]
    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom pain on swallowing over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  4. Change in evaluation of dry mucosa [ Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) ]
    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom dry mucosa over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  5. Change in decreased saliva release [ Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) ]
    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom decreased saliva release over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  6. Change in Irritation of mucosa [ Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) ]
    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom irritation of mucosa over time on a 4-category scale ranging from 1 (none) to 4 (severe).

  7. Change in swelling [ Time Frame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days) ]
    A patient-reported oral mucositis symptom score scale will be assessed to determine the severity of the symptom swelling over time on a 4-category scale ranging from 1 (none) to 4 (severe).


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by the Suspect Adverse Reaction Report Form (CIOMS Form I). [ Time Frame: within 21 days after starting chemotherapy ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with radio- and/or chemotherapy-induced mucositis
Criteria

Inclusion Criteria:

  • Patients receiving radio- and/or chemotherapy (sutent) and suffering from mucositis
  • Female or male individuals ≥ 18 years

Exclusion Criteria:

  • Male or female under 18 years
  • Any disease that can, in the opinion of the treating physician, affect the outcome of the study
  • Patients with known intolerance to one of the substances used
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816515


Locations
Layout table for location information
Hungary
Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary
Budapest, Hungary, 1026
National Koranyi Institute of TB and Pulmonology
Budapest, Hungary, 1121
National Institute of Oncology, Department of Radiotherapy 7-9 Ráth György u.
Budapest, Hungary
Sponsors and Collaborators
Bitop AG
Investigators
Layout table for investigator information
Principal Investigator: Lajos Géczi, PhD National Institute of TB and Pulmonology

Layout table for additonal information
Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT02816515     History of Changes
Other Study ID Numbers: 2016/EML/NIS
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Keywords provided by Bitop AG:
Non interventional study
Ectoin
Mouth wash
Mucositis
Chemotherapy
Radiotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases