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

Not yet recruiting

• Conditions: Malignant neoplasms of lip, oral cavity and pharynx. Ayurveda Condition: ARBUDAH,

• Registration Number: CTRI/2022/11/047416
• Lead Sponsor: Dr Harikrishnan MD Ayu

Brief Summary

• This is a pilot clinical study

• Head and neck cancer patients undergoing radiation or chemoradiation will be included in this study

• All patients will be started on Oral Disintegration Tablet from Day 1 of chemoradiation and will be continued for a period of 3 months

• Assessment criteria - Xerostomia Inventory [subjective] and Clinical Oral Dryness Score - CODS [objective]

• Assessment - Base line [Prior to treatment], at completion of RT [1.5 months] , at first follow up [3 months] and at 6 months

• The primary end point is to assess the change in CODS at 6 months from the base line

• The secondary end point is to assess whether the subjective scoring [Xerostomia Inventory score] is correlating with the objective CODS

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

• 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 assessment	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	correlating with the objective Clinical Oral Dryness Score

Trial Locations

Locations (1)

Cancer Institute (WIA); 🇮🇳 Chennai, TAMIL NADU, India

Cancer Institute (WIA)

🇮🇳Chennai, TAMIL NADU, India

Dr Ram Madhavan MD

Principal investigator

8281796896

drrammadhavan@gmail.com