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

September 12, 2018 updated by: Istituto Oncologico Veneto IRCCS

Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35100
        • Radiotherapy Department, Istituto Oncologico Veneto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically proven squamous cell carcinomas of the head-and-neck
  • Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx
  • Stage III or IV disease without evidence of distant metastases
  • Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy
  • Age ≥ 18 years
  • Karnofsky Performance Status ≥70
  • Life expectancy ≥6 months
  • Able to swallow and retain oral medication
  • Good state of dentition
  • Patients must be available for treatment and follow-up
  • Confirmation of adequate contraception use by the patient and/or partner
  • Signed informed consent

Exclusion Criteria:

  • Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx
  • Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities.
  • Chronic administration of steroids or immunosuppressants
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAMITAL® sachets, oral suspension
SAMITAL® sachets for oral suspension, 20 mL, four times a day.
Drug: SAMITAL®
Placebo Comparator: Placebo sachets
Placebo sachets for oral suspension, 20 mL, four times a day.
Drug: Placebo sachets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developing at any time during the whole study period.
Time Frame: Within 19 weeks after starting Radiotherapy
Within 19 weeks after starting Radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)
Time Frame: Within 19 weeks after starting Radiotherapy
Within 19 weeks after starting Radiotherapy

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life assessed by European Organization for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) and specific head and neck module (QLQ-H&N35)
Time Frame: Within 19 weeks after starting Radiotherapy
Within 19 weeks after starting Radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Oncologico Veneto IRCCS

Collaborators

Indena S.p.A

Investigators

  • Principal Investigator: Lucio Loreggian, MD, Radiotherapy Department, Istituto Oncologico Veneto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-HN-1-2012 ROSAM
  • 2012-002046-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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