Effect of Bacillus clausii Spores in the relief of mouth ulcers in Cancer Patients Undergoing Radiation Therapy
Phase 4
Completed
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2018/12/016748
- Lead Sponsor
- Self
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
1. Patients diagnosed with head and neck cancer receiving RT dose around 6000-7000 cGy with or without concomitant chemotherapy.
2. Patients willing to give written informed consent
Exclusion Criteria
1.Severe oral fibrosis or stomatitis at the time of screening.
2.Other comorbidities like hepatic, renal impairment and cardiac failure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time taken for appearance of mucositis in each group <br/ ><br>2. Time for resolution of mucositis. <br/ ><br>3.Severity of mucositis in each group. <br/ ><br>Timepoint: day 0, 7, 14, 21,28, 35, 42, 49 from onset of RT
- Secondary Outcome Measures
Name Time Method 1.Time taken for appearance of mucositis in each group <br/ ><br>2. Time for resolution of mucositis.Timepoint: day 0, 7, 14, 21,28, 35, 42, 49 from onset of RT