NCT02816515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

June 20, 2016

Last Update Submit

January 17, 2018

Conditions

Mucositis

Keywords

Non interventional studyEctoinMouth washMucositisChemotherapyRadiotherapy

Outcome Measures

Primary Outcomes (7)

  • Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort

    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

    Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

  • 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.

    day 21

  • Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire

    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).

    Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

  • Change in evaluation of dry mucosa

    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).

    Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

  • Change in decreased saliva release

    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).

    Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

  • Change in Irritation of mucosa

    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).

    Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

  • Change in swelling

    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).

    Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by the Suspect Adverse Reaction Report Form (CIOMS Form I).

    within 21 days after starting chemotherapy

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with radio- and/or chemotherapy-induced mucositis

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary

Budapest, 1026, Hungary

Location

National Koranyi Institute of TB and Pulmonology

Budapest, 1121, Hungary

Location

National Institute of Oncology, Department of Radiotherapy 7-9 Ráth György u.

Budapest, Hungary

Location

Related Publications (1)

  • Dao VA, Bilstein A, Overhagen S, Geczi L, Barath Z, Mosges R. Effectiveness, Tolerability, and Safety of Ectoine-Containing Mouthwash Versus Those of a Calcium Phosphate Mouthwash for the Treatment of Chemotherapy-Induced Oral Mucositis: A Prospective, Active-Controlled, Non-interventional Study. Oncol Ther. 2018 Jun;6(1):59-72. doi: 10.1007/s40487-018-0060-z. Epub 2018 May 9.

    PMID: 32700140DERIVED

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Lajos Géczi, PhD

    National Institute of TB and Pulmonology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 28, 2016

Study Start

January 1, 2016

Primary Completion

October 24, 2017

Study Completion

October 24, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

HU(3)