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

NCT ID: NCT01941992

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-01-31

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.

Conditions

Head-and-neck Squamous Cell Carcinoma; Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAMITAL® sachets, oral suspension

SAMITAL® sachets for oral suspension, 20 mL, four times a day.

Group Type: EXPERIMENTAL

SAMITAL®

Intervention Type: DRUG

Placebo sachets

Placebo sachets for oral suspension, 20 mL, four times a day.

Group Type: PLACEBO_COMPARATOR

Placebo sachets

Intervention Type: DRUG

Interventions

SAMITAL®

Intervention Type: DRUG

Placebo sachets

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indena S.p.A

INDUSTRY

Sponsor Role: collaborator

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucio Loreggian, MD

Role: PRINCIPAL_INVESTIGATOR

Radiotherapy Department, Istituto Oncologico Veneto

Locations

Radiotherapy Department, Istituto Oncologico Veneto

Padua, , Italy

Countries

Italy

References

Fasanaro 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.

Reference Type: DERIVED

PMID: 36551677 (View on PubMed)

Other Identifiers

2012-002046-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IOV-HN-1-2012 ROSAM

Identifier Type: -

Identifier Source: org_study_id