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Clinical Trials/NCT01941992
NCT01941992CompletedPhase 2

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.

Istituto Oncologico Veneto IRCCS1 site in 1 country120 target enrollmentStarted: December 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

SAMITAL® sachets, oral suspension

Experimental

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

Intervention: SAMITAL® (Drug)

Placebo sachets

Placebo Comparator

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

Intervention: Placebo sachets (Drug)

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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