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Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients

NCT01941992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-09-13

No results posted yet for this study

Summary

The purpose of this study is to:

* evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
* assess tolerability of SAMITAL and the impact on patients reported outcomes.

Conditions

  • Head-and-neck Squamous Cell Carcinoma
  • Oral Mucositis

Interventions

DRUG

SAMITAL®

DRUG

Placebo sachets

Sponsors & Collaborators

  • Indena S.p.A

    collaborator INDUSTRY

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Principal Investigators

  • Lucio Loreggian, MD · Radiotherapy Department, Istituto Oncologico Veneto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-12-31
Completion
2018-01-31

Countries

  • Italy

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 NCT01941992 on ClinicalTrials.gov