Overview

This trial is active, not recruiting.

Conditions head-and-neck squamous cell carcinoma, oral mucositis.
Treatments samital®, placebo sachets
Phase phase 2
Sponsor Istituto Oncologico Veneto IRCCS
Collaborator Indena S.p.A
Start date December 2012
End date December 2016
Trial size 120 participants
Trial identifier NCT01941992, 2012-002046-20, IOV-HN-1-2012 ROSAM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
SAMITAL® sachets for oral suspension, 20 mL, four times a day.
samital®
(Placebo Comparator)
Placebo sachets for oral suspension, 20 mL, four times a day.
placebo sachets

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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.
Principal investigator Lucio Loreggian, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Istituto Oncologico Veneto IRCCS.