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A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis

NCT02399228 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-11-19

Study results available
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Summary

The initial proposed clinical study will be conducted in adult head and neck cancer subjects. This will be an open-labeled, proof of concept trial to evaluate the efficacy, safety and tolerability of EISO in a form of oral rinse as adjunctive therapy to standard of care. Santalis believes that the proposed study is a prudent and appropriate approach to investigate the potential of their product to prevent or improve oral mucositis symptoms commonly seen in subjects undergoing radiotherapy with or without chemotherapy.

Conditions

  • Oral Mucositis

Interventions

DRUG

0.25% EISO mouth rinse

A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • Santalis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Castella, PhD · Santalis Pharmaceuticals

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-04
Primary Completion
2017-05-20
Completion
2017-05-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02399228 on ClinicalTrials.gov