Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients (ROSAM)
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|ClinicalTrials.gov Identifier: NCT01941992|
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : September 13, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: SAMITAL® sachets, oral suspension
SAMITAL® sachets for oral suspension, 20 mL, four times a day.
Placebo Comparator: Placebo sachets
Placebo sachets for oral suspension, 20 mL, four times a day.
Drug: Placebo sachets
- 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 ]
- 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 ]
- 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 ]
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
|Radiotherapy Department, Istituto Oncologico Veneto|
|Padova, Italy, 35100|
|Principal Investigator:||Lucio Loreggian, MD||Radiotherapy Department, Istituto Oncologico Veneto|