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

NCT01707641 | Unknown Phase 4

• 1 other identifier: CD2 AIRO
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Mucositis

Outcome Measures

Primary Outcomes (1)

• incidence of grade III/IV mucositis

  Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)

  2 months

Secondary Outcomes (1)

• percentage of patients able to complete the chemo-radiotherapy treatment

  2 months

Other Outcomes (1)

• percentage of patients who need enteral nutrition

  2 months from enrolment

Study Arms (2)

CD#2

ACTIVE COMPARATOR

patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2

Dietary Supplement: CD#2

bicarbonate sodium mouthwash

ACTIVE COMPARATOR

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

Other: bicarbonate sodium mouthwash

Interventions

CD#2 DIETARY_SUPPLEMENT

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

Also known as: Lozenge containing Lactobacillus brevis CD2

CD#2

bicarbonate sodium mouthwash OTHER

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

bicarbonate sodium mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male and female patients \> 18 years of age
• Karnofsky Performance Status \>70%
• pathological and histological diagnosis that confirms head and neck tumour
• patients eligible for radical radiotherapy and/or chemotherapy
• expected survival time \> 6 months
• normal bone marrow function (neutrophil count \>1500/cmm, platelet count \> 100.000/CMM)
• serum creatine \< 1.8mg/dl
• total bilirubin \<2mg/dl
• GOT, GPT within 3 times the normal limit
• willingness to perform conventional 3D radiotherapy or intensive modulated radiation therapy with concurrent chemotherapy
• signed informed consent form

You may not qualify if:

• Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
• Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
• Major surgery of the oral cavity within the last 4 weeks
• Patients previoucly treated with radiotherapy of head and neck
• Antifungal or antiviral therapy for oral pathological conditions in the last
• Other serious concomitant disease
• History of insulin-dependent Diabetes Mellituss
• History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis or Xerostomia
• Patients with body weigh \>35 kg
• Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant
• Patients with Hepatitis B / C
• Patients with symptomatic untreated dental infection
• Patients with oral mucositis grade NCICTC 3 or 4
• Histological and pathological diagnosis unavailable
• Patients with signs and symptoms of systemic infection

Sponsors & Collaborators

• S. Andrea Hospital: lead

Study Sites (1)

Sant'Andrea Hospital

Rome, Rome, 00189, Italy

RECRUITING

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Vitaliana De Sanctis, PhD

  Sant'Andrea Hospital - Radiotherapy Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitaliana De Sanctis, PhD

CONTACT

vitaliana.desanctis@uniroma1.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. University Researcher

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2019
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

IT (1)