Trial | NCT01941992  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    samital ...

  • Study Participants

    120
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.
Study Started
Dec 31
2012
Primary Completion
Dec 31
2016
Study Completion
Jan 31
2018
Last Update
Sep 13
2018

Drug Placebo sachets

Drug SAMITAL®

SAMITAL® sachets, oral suspension Experimental

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

Placebo sachets Placebo Comparator

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

Criteria 

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.
No Results Posted