A clinical trial to study the efficacy of probiotic Lactobacillus brevis lozenges in preventing radiation and chemotherapy induced oral mucositis in head and neck cancer patients.

A randomized double blind study of efficacy of Lactobacillus brevis CD2 lozenges in preventing radiation and chemotherapy induced oral mucositis in head and neck cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000117

Enrollment

200

Registered

2008-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Lactobacillus CD2 lozenges: 6 lozenges per day, from the day when the radiation &amp

Chemotherapy begins and continued a week after that (about 8-11 weeks) Control Intervention1: Placebo: 6 lozenges per day, from the day when the radiation &amp

Chemotherapy begins and continued a week after that (about 8-11 weeks)

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria 1.Age between 18 and 70 years. 2.Karnofsky Performance Score &#8805; 70%. 3.Confirmed histological diagnosis of cancer of head and/or neck area. 4.Patient not previously treated with chemotherapy and/or radiotherapy except the patients who have received neoadjuvant chemotherapy for current head and neck cancer. 5.Patients eligible to receive chemotherapy and/or radiotherapy. 6.Concomitant co morbid condition if present, controlled by medicines. 7.No distant metastasis. 8.Normal bone marrow functions ANC (Absolute neutrophil count) &#8805;1500/cmm, platelets counts &#61502; 1, 00,000/cmm). 9.Serum creatinine<1.8mg/dl. 10.Total bilirubin=< 2mg/dl. 11.Liver enzymes within three times of normal limit. 12.Expected survival > 6 months. 13.Planning to receive a total radiation dose &#8805; 5500 cGy, administered in a single daily fraction of 180 - 220 cGy (5 days a week) or twice daily fractions of 110 - 150 cGy.

Exclusion criteria

Exclusion criteria: 1.Patients weighing less than 35 kgs. 2.Pregnant women and lactating mothers. 3.Patients with history of AIDS, Hepatitis B/ C. 4.Patients who have taken any other investigational product in last 4 weeks. 5.Patients having untreated symptomatic dental infection. 6.Patients with WHO Grade 3 or 4 oral Mucositis. 7.Other serious concurrent illness. 8.History of Insulin Dependent Diabetes Mellitus. 9.Inconclusive histological diagnosis. 10.Patients on anticancer antibiotics. 11.Patients with signs and symptoms of systemic infections. 12.Patient?s refusal to sign informed consent.

Design outcomes

Secondary

Measure	Time frame
1.Determine the incidence of Grade I and II mucositis in patients with head and neck cancer undergoing chemotherapy and/or radiotherapy (NCICT for Oral mucositis grading) 2.Time period for healing of chemotherapy and/or radiotherapy induced oral mucositis. 3.Quality of life (QoL) in test and control group (FACT H & N version 4) 4.Tolerance to the treatment regimen. 5.Weight loss. Timepoint: Every week continued till end of RT and CT	—

Measure

Time frame

1.Determine the incidence of Grade I and II mucositis in patients with head and neck cancer undergoing chemotherapy and/or radiotherapy (NCICT for Oral mucositis grading) 2.Time period for healing of chemotherapy and/or radiotherapy induced oral mucositis. 3.Quality of life (QoL) in test and control group (FACT H & N version 4) 4.Tolerance to the treatment regimen. 5.Weight loss. Timepoint: Every week continued till end of RT and CT

—

Primary

Measure	Time frame
1.Determine the incidence of grade III and IV mucositis in patients with head and neck cancer undergoing chemotherapy and/or radiotherapy [National Cancer Institute Common Toxicity Criteria (NCICTC) for Oral mucositis grading] 2.Percentage of patients able to complete the treatment Timepoint: Every week continued till end of RT and CT	—

Countries

India

Contacts

Public ContactDr. Atul Sharma

AIIMS

atul1@hotmail.com9818548149

Outcome results