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

Phase 2

Completed

• Conditions: Oral Mucositis; Head-and-neck Squamous Cell Carcinoma
• Interventions: Drug: SAMITAL®; Drug: Placebo sachets

• Registration Number: NCT01941992
• Lead Sponsor: Istituto Oncologico Veneto IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Primary Completion: 2016-12
• Study Completion: 2018-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAMITAL® sachets, oral suspension	SAMITAL®	SAMITAL® sachets for oral suspension, 20 mL, four times a day.
Placebo sachets	Placebo sachets	Placebo sachets for oral suspension, 20 mL, four times a day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Radiotherapy Department, Istituto Oncologico Veneto; 🇮🇹 Padova, Italy