Clinical trial NCT02816515: Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Official title: Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucositis
Keywords: Non interventional study
Ectoin
Mouth wash
Mucositis
Chemotherapy
Radiotherapy
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with radio- and/or chemotherapy-induced mucositis

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.


Eligibility 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

Primary outcomes:
measure: Change in severity of oral mucositis as assessed by a visual examination and asking the patient about pain and discomfort
timeFrame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
measure: 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.
timeFrame: day 21
measure: Change in evaluation of pain on swallowing by using a patient-reported oral mucositis experience questionaire
timeFrame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
measure: Change in evaluation of dry mucosa
timeFrame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
measure: Change in decreased saliva release
timeFrame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
measure: Change in Irritation of mucosa
timeFrame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
measure: Change in swelling
timeFrame: Visit 1(day 0), Visit 2(after 7 days), Visit 3 (after 14 days) and Visit 4 (after 21 days)
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by the Suspect Adverse Reaction Report Form (CIOMS Form I).
timeFrame: within 21 days after starting chemotherapy
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Department of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary
city: Budapest
country: Hungary
facility: National Koranyi Institute of TB and Pulmonology
city: Budapest
country: Hungary
facility: National Institute of Oncology, Department of Radiotherapy 7-9 Ráth György u.
Study officials:
affiliation: National Institute of TB and Pulmonology
name: Lajos Géczi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.