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

Oral Mucositis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941992
• Other study ID #: IOV-HN-1-2012 ROSAM
• Secondary ID: 2012-002046-20
• Status: Completed
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: January 2018

Study information

• Verified date: September 2018
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head-and-neck Squamous Cell Carcinoma
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• SAMITAL®

• Placebo sachets

Locations

Country	Name	City	State
Italy	Radiotherapy Department, Istituto Oncologico Veneto	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS	Indena S.p.A

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)		Within 19 weeks after starting Radiotherapy
Primary	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.		Within 19 weeks after starting Radiotherapy
Secondary	Incidence of adverse events assessed by NCI-Common Terminology Criteria for Adverse Effects (CTCAE version 4.0)		Within 19 weeks after starting Radiotherapy