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Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer

NCT01707641 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-05-20

No results posted yet for this study

Summary

Oral mucositis is a debilitating side effect for oncology patients and there is a clear need for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a potential new alternative for the prevention of grade III and IV mucositis. The main endpoint of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of grade III and IV mucositis as well as increase the percentage of patients who will complete the radio-chemotherapy treatment.

Conditions

Interventions

DIETARY_SUPPLEMENT

CD#2

patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth

OTHER

bicarbonate sodium mouthwash

Patients will be asked to wash their mouth with bicarbonate sodium several times per day

Sponsors & Collaborators

  • S. Andrea Hospital

    lead OTHER

Principal Investigators

  • Vitaliana De Sanctis, PhD · Sant'Andrea Hospital - Radiotherapy Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-12-31
Completion
2019-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01707641 on ClinicalTrials.gov