NCT01941992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

4 years

First QC Date

August 8, 2013

Last Update Submit

September 12, 2018

Conditions

Head-and-neck Squamous Cell CarcinomaOral Mucositis

Keywords

head and neckSquamous Cell Carcinomaoral mucositisChemo-radiotherapy

Outcome Measures

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.

    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)

    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)

    Within 19 weeks after starting Radiotherapy

Study Arms (2)

SAMITAL® sachets, oral suspension

EXPERIMENTAL

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

Drug: SAMITAL®

Placebo sachets

PLACEBO COMPARATOR

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

Drug: Placebo sachets

Interventions

SAMITAL®DRUG
SAMITAL® sachets, oral suspension
Placebo sachetsDRUG
Placebo sachets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiotherapy Department, Istituto Oncologico Veneto

Padua, 35100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36551677DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckStomatitisCarcinoma, Squamous Cell

Interventions

samital

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteMouth DiseasesStomatognathic DiseasesNeoplasms, Squamous Cell

Study Officials

  • Lucio Loreggian, MD

    Radiotherapy Department, Istituto Oncologico Veneto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2013

First Posted

September 13, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2016

Study Completion

January 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)