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Completed

NCT Number: NCT01941992

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

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.

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Key information

Conditions

Head-and-neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oral Mucositis Squamous Cell Carcinoma of Head and Neck Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Radiotherapy Department, Istituto Oncologico Veneto

Padova, 35100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAMITAL®

Drug

Placebo sachets

Drug

Primary outcomes

  1. 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

  1. 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

Other outcomes

  1. 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)

    Time frame: Within 19 weeks after starting Radiotherapy

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Collaborators

  • Indena S.p.A

Registry information

Official study 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.

Acronym: ROSAM

Important dates

Study start
2012
Primary completion
2016
Study completion
2018
First posted
Sep 13, 2013
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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