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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941992

Acronym

ROSAM

Enrollment

120

Registered

2013-09-13

Start date

2012-12-31

Completion date

2018-01-31

Last updated

2018-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head-and-neck Squamous Cell Carcinoma, Oral Mucositis

Keywords

head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy

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.

Interventions

DRUGSAMITAL®

DRUGPlacebo sachets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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.	Within 19 weeks after starting Radiotherapy

Secondary

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

Other

Measure	Time frame
Quality of life assessed by European Organization for Research and Treatment of Cancer quality of life core questionnaire (EORTC QLQ-C30) and specific head and neck module (QLQ-H&N35)	Within 19 weeks after starting Radiotherapy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026