Clinical trial · Interventional
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.
NCT01941992CI-TRIAL-00034844ROSAMcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head-and-neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo sachets | Drug | — | UNRESOLVED |
| SAMITAL® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SAMITAL® sachets, oral suspension
- description
- SAMITAL® sachets for oral suspension, 20 mL, four times a day.
- interventionNames
- Drug: SAMITAL®
- type
- PLACEBO_COMPARATOR
- label
- Placebo sachets
- description
- Placebo sachets for oral suspension, 20 mL, four times a day.
- interventionNames
- Drug: Placebo sachets
Primary outcomes (1)
- measure
- 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.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFasanaro E, Del Bianco P, Groff E, Riva A, Petrangolini G, Busato F, Stritoni P, Scarzello G, Loreggian L, De Salvo GL. Role of SAMITAL in the Prevention and Treatment of Chemo-Radiotherapy-Induced Oral Mucositis in Head and Neck Carcinoma: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (ROSAM). Cancers (Basel). 2022 Dec 15;14(24):6192. doi: 10.3390/cancers14246192. PMID 36551677