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.

Phase 3

Completed

Registration Number: CTRI/2008/091/000117

Lead Sponsor: CD Pharma India Pvt. Ltd. C 1/53, Ist floor, SDA, New Delhi-110016, Tel.01141759898, Fax. 01141759894

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria
1.Age between 18 and 70 years.
2.Karnofsky Performance Score ≥ 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) ≥1500/cmm, platelets counts  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 ≥ 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]<br>2.Percentage of patients able to complete the treatment<br>Timepoint: Every week continued till end of RT and CT

Secondary Outcome Measures

Name	Time	Method
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)<br>2.Time period for healing of chemotherapy and/or radiotherapy induced oral mucositis.<br>3.Quality of life (QoL) in test and control group (FACT H & N version 4) <br>4.Tolerance to the treatment regimen.<br>5.Weight loss.<br>Timepoint: Every week continued till end of RT and CT