Role of SAMITAL in the relief of chemo-radiation (CT-RT) induced oral mucositis in head and neck cancer patients. A Phase II placebo controlled randomised trial.
- Conditions
- Head-and-neck cancer (Squamous cell carcinomas)MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002046-20-IT
- Lead Sponsor
- ISTITUTO ONCOLOGICO VENETO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
•Histologically proven squamous cell carcinomas of the head-and-neck; •primary tumor sites eligible: 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 chemoradiotherapy; •age 18-75 years; •Karnofsky Performance Status =70; •life expectancy =6 months; able to swallow and retain oral medication; •good state of dentation; •patients must be available for treatment and follow-up; •insurance by the patient and/or partner who will use adequate contraception; •signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
•Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx; •seroius comorbidities: uncontrolled heart disease, heart failure within 6 months prior to study partecipation, history of serious neurological and/or psychiatric abnormality; •chronic administration of steroids or immunosuppressant; •pregnant female.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing to chemo-radiotherapy.;Secondary Objective: Assess tolerability of SAMITAL and the impact on patients reported outcomes.;Primary end point(s): Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developed at any time during the whole study period.;Timepoint(s) of evaluation of this end point: Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Incidence of adverse events assessed by NCI-CTCAE version 4.0; •Days of CT-RT treatment interruption and their period suspection; •Use of enteral or parenteral nutritional support; •Weight loss; •Use of analgesic drugs during CT-RT; •Changes of the Karnofsky Performance Status at the 11th week; •Quality of life assessed by EORTC QLQ-C30 and QLQ-H&N35; •Grade of Xerostomia and its trend over time assessed by Xerostomia Questionnaire.;Timepoint(s) of evaluation of this end point: Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy. For the quality of life, at 4th, 7th, 11th and 23rd weeks.