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

A pilot study on the feasibility and efficacy of Oral Disintegration Tablet (ODT), containing polyherbal extracts, a dietary supplement in the management of Xerostomia in Head and Neck Cancer patients receiving radiation treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/047416

Enrollment

Registered

2022-11-18

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Lymphoma histology 2. Patients undergoing re irradiation 3. Patients with comorbidities

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess whether the subjective scoring [Xerostomia Inventory score] is correlating with the objective Clinical Oral Dryness Score Timepoint: base line, completion of treatment, 3 months follow up and 6 months follow up	—

Countries

India

Contacts

Public ContactDr M Harikrishnan MD Ayu

Cancer Institute [WIA] Adyar

drrammadhavan@gmail.com8281796896

Outcome results