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

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Bitop

Status

Completed

Conditions

Mucositis

Study type

Observational

Funder types

Industry

Identifiers

NCT02816515
2016/EML/NIS

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

46 participants in 3 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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