Role of SAMITAL in the relief of chemo-radiation (CT-RT) induced oral mucositis in head and neck cancer patients. A Phase II placebo controlled randomised trial.

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. - IOV-HN-1-2012 (ROSAM)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002046-20-IT

Enrollment

120

Registered

2012-07-23

Start date

2012-05-28

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head-and-neck cancer (Squamous cell carcinomas) MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: SAMITAL Product Code: NA Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: VACCINIUM MYRTILLUS CAS Number: 8001000-49-5 Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Histologically proven squamous cell carcinomas of the head-and-neck; •primary tumor sites eligible: 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 chemoradiotherapy; •age 18-75 years; •Karnofsky Performance Status =70; •life expectancy =6 months; able to swallow and retain oral medication; •good state of dentation; •patients must be available for treatment and follow-up; •insurance by the patient and/or partner who will use adequate contraception; •signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: •Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx; •seroius comorbidities: uncontrolled heart disease, heart failure within 6 months prior to study partecipation, history of serious neurological and/or psychiatric abnormality; •chronic administration of steroids or immunosuppressant; •pregnant female.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing to chemo-radiotherapy.;Secondary Objective: Assess tolerability of SAMITAL and the impact on patients reported outcomes.;Primary end point(s): Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developed at any time during the whole study period.;Timepoint(s) of evaluation of this end point: Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy.	—

Measure

Time frame

Main Objective: Evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing to chemo-radiotherapy.;Secondary Objective: Assess tolerability of SAMITAL and the impact on patients reported outcomes.;Primary end point(s): Proportion of subjects with Grade III or IV of mucositis assessed by the WHO mucositis scale, developed at any time during the whole study period.;Timepoint(s) of evaluation of this end point: Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy.

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Secondary

Measure	Time frame
Secondary end point(s): •Incidence of adverse events assessed by NCI-CTCAE version 4.0; •Days of CT-RT treatment interruption and their period suspection; •Use of enteral or parenteral nutritional support; •Weight loss; •Use of analgesic drugs during CT-RT; •Changes of the Karnofsky Performance Status at the 11th week; •Quality of life assessed by EORTC QLQ-C30 and QLQ-H&N35; •Grade of Xerostomia and its trend over time assessed by Xerostomia Questionnaire.;Timepoint(s) of evaluation of this end point: Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy. For the quality of life, at 4th, 7th, 11th and 23rd weeks.	—

Measure

Time frame

Secondary end point(s): •Incidence of adverse events assessed by NCI-CTCAE version 4.0; •Days of CT-RT treatment interruption and their period suspection; •Use of enteral or parenteral nutritional support; •Weight loss; •Use of analgesic drugs during CT-RT; •Changes of the Karnofsky Performance Status at the 11th week; •Quality of life assessed by EORTC QLQ-C30 and QLQ-H&N35; •Grade of Xerostomia and its trend over time assessed by Xerostomia Questionnaire.;Timepoint(s) of evaluation of this end point: Weekly during radiotherapy, at 4th week and 3 months after the end of radiotherapy. For the quality of life, at 4th, 7th, 11th and 23rd weeks.

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Countries

Italy

Contacts

Public ContactSperim. Cliniche e Biostatistica

Istituto Oncologico Veneto

gianluca.desalvo@unipd.it049/8215704-5710

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026