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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01941992
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Indena S.p.A
Information provided by (Responsible Party):
Istituto Oncologico Veneto IRCCS

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.

Condition or disease Intervention/treatment Phase
Head-and-neck Squamous Cell Carcinoma Oral Mucositis Drug: SAMITAL® Drug: Placebo sachets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SAMITAL® sachets, oral suspension
SAMITAL® sachets for oral suspension, 20 mL, four times a day.
Drug: SAMITAL®
Placebo Comparator: Placebo sachets
Placebo sachets for oral suspension, 20 mL, four times a day.
Drug: Placebo sachets



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941992


Locations
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Italy
Radiotherapy Department, Istituto Oncologico Veneto
Padova, Italy, 35100
Sponsors and Collaborators
Istituto Oncologico Veneto IRCCS
Indena S.p.A
Investigators
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Principal Investigator: Lucio Loreggian, MD Radiotherapy Department, Istituto Oncologico Veneto
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Responsible Party: Istituto Oncologico Veneto IRCCS
ClinicalTrials.gov Identifier: NCT01941992    
Other Study ID Numbers: IOV-HN-1-2012 ROSAM
2012-002046-20 ( EudraCT Number )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Istituto Oncologico Veneto IRCCS:
head and neck
Squamous Cell Carcinoma
oral mucositis
Chemo-radiotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Mucositis
Stomatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Head and Neck Neoplasms
Neoplasms by Site