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

Istituto Oncologico Veneto IRCCS

Status and phase: Completed; Phase 2

Conditions: Head-and-neck Squamous Cell Carcinoma; Oral Mucositis

Treatments: Drug: SAMITAL®; Drug: Placebo sachets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01941992

2012-002046-20 (EudraCT Number)

IOV-HN-1-2012 ROSAM

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

SAMITAL® sachets, oral suspension

Experimental group

Description:

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

Treatment:

Drug: SAMITAL®

Placebo sachets

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo sachets