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

Primary Purpose

Head-and-neck Squamous Cell Carcinoma, Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
SAMITAL®
Placebo sachets
Sponsored by
Istituto Oncologico Veneto IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head-and-neck Squamous Cell Carcinoma focused on measuring head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radiotherapy Department, Istituto Oncologico Veneto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAMITAL® sachets, oral suspension

Placebo sachets

Arm Description

SAMITAL® sachets for oral suspension, 20 mL, four times a day.

Placebo sachets for oral suspension, 20 mL, four times a day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)

Full Information

First Posted
August 8, 2013
Last Updated
September 12, 2018
Sponsor
Istituto Oncologico Veneto IRCCS
Collaborators
Indena S.p.A
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1. Study Identification

Unique Protocol Identification Number
NCT01941992
Brief Title
Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
Acronym
ROSAM
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Oncologico Veneto IRCCS
Collaborators
Indena S.p.A

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head-and-neck Squamous Cell Carcinoma, Oral Mucositis
Keywords
head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAMITAL® sachets, oral suspension
Arm Type
Experimental
Arm Description
SAMITAL® sachets for oral suspension, 20 mL, four times a day.
Arm Title
Placebo sachets
Arm Type
Placebo Comparator
Arm Description
Placebo sachets for oral suspension, 20 mL, four times a day.
Intervention Type
Drug
Intervention Name(s)
SAMITAL®
Intervention Type
Drug
Intervention Name(s)
Placebo sachets
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucio Loreggian, MD
Organizational Affiliation
Radiotherapy Department, Istituto Oncologico Veneto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiotherapy Department, Istituto Oncologico Veneto
City
Padova
ZIP/Postal Code
35100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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