A study on the efficacy of Oral Disintegration Tablet (ODT), a dietary supplement containing polyherbal extracts in the management of Xerostomia in Head and Neck Cancer patients receiving radiation treatment
Phase 2
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2022/11/047416
- Lead Sponsor
- Dr Harikrishnan MD Ayu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. ECOG Performance status I and II
2. Patients treated with two opposing lateral fields
including parotid using 2D technique
3. Patients undergoing radiation or chemoradiation
Exclusion Criteria
1. Lymphoma histology
2. Patients undergoing re irradiation
3. Patients with comorbidities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To analyse the change in the Clinical Oral Dryness Score from the baseline at the time of final assessmentTimepoint: base line, completion of treatment, 3 months follow up and 6 months follow up
- Secondary Outcome Measures
Name Time Method To assess whether the subjective scoring [Xerostomia Inventory score] is <br/ ><br>correlating with the objective Clinical Oral Dryness Score <br/ ><br>Timepoint: base line, completion of treatment, 3 months follow up and 6 months follow up